Data / Medical devices / United States / Carolina Liquid Chemistries
Carolina Liquid Chemistries: FDA-registered device maker in Brea, CA, United States, 69 510(k) clearances
Carolina Liquid Chemistries is registered with the FDA (registration 2030861) in Brea, CA, United States. It lists 57 device types. The FDA files 69 510(k) clearances under its listings, the newest dated December 13, 2022. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2030861
- FEI number
- 3000215862
- Address
- 510 W Central Ave Ste C, Brea, CA, United States, 92821
- Owner or operator
- Diazyme Laboratories, Inc. (9057184)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 6, 2026
- Registered through
- 2027
- Brand names listed
- 6-AM Reagent, ALB (G) Reagent, ALB (P), ALP Reagent, ALT Reagent, AMPH Reagent, AMY, AST Reagent and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2022 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | DJG | Substantially Equivalent | Shenzhen Superbio Technology Co., Ltd. | accessdata.fda.gov |
| December 3, 2018 | K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 26, 2017 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| March 9, 2015 | K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| July 1, 2014 | K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| June 13, 2014 | K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 16, 2014 | K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | JJE | Substantially Equivalent | Carolina Liquid Chemistries Corp. | accessdata.fda.gov |
| May 8, 2014 | K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | LBS | Substantially Equivalent | Carolina Liquid Chemistries Corp. | accessdata.fda.gov |
| June 1, 2012 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| January 23, 2012 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | LAF | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 22, 2011 | K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 15, 2011 | K110298 | OPIATE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| March 24, 2011 | K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | DIF | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| July 6, 2010 | K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 29, 2010 | K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | DCF | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| June 5, 2009 | K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | JIX | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| April 30, 2007 | K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | KHS | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| April 13, 2007 | K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | JIX | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| December 27, 2004 | K040977 | GENCHEM ELECTROLYTE BUFFER | JGS | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| December 27, 2004 | K040976 | GENCHEM CREATININE REAGENT | CGX | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| December 27, 2004 | K040975 | GENCHEM CO2 ACID REAGENT | JFL | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| December 27, 2004 | K040972 | CALCIUM, AZO DYE REAGENT | CJY | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| December 22, 2004 | K040971 | GENCHEM ISE ELECTROLYTE REFERENCE | JGS | Substantially Equivalent | Genchem, Inc. | accessdata.fda.gov |
| May 28, 2004 | K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | DIF | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 27, 2004 | K040411 | DRI OXYCODONE ASSAY | LAS | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| November 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 3, 2003 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | DIC | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| September 5, 2003 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| August 27, 2003 | K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 6, 2003 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| February 4, 2003 | K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR | DCK | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| January 21, 2003 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | JXN | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 17, 2002 | K021636 | ALBUMIN REAGENT | CJW | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
| June 4, 2002 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | LCM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| August 27, 2001 | K012110 | DRI ECSTASY ENZYME IMMUNOASSAY | DKZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 27, 2001 | K011972 | DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
| August 21, 2001 | K012038 | JAS URIC ACID LIQUID REAGENT | KNK | Substantially Equivalent | Jas Diagnostics, Inc. | accessdata.fda.gov |
| June 20, 2001 | K011150 | DRIDAU OPIATE ASSAY | DJG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| March 23, 2001 | K003835 | JAS MAGNESIUM REAGENT | JGJ | Substantially Equivalent | Jas Diagnostics, Inc. | accessdata.fda.gov |
| February 21, 2001 | K003912 | PHOSPHORUS REAGENT | CEO | Substantially Equivalent | Jas Diagnostics, Inc. | accessdata.fda.gov |
| February 20, 2001 | K003892 | TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
| October 13, 2000 | K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | DCK | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 22, 1998 | K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | MRR | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| February 13, 1998 | K974833 | CK-NAC REAGENT | CGS | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
| October 8, 1997 | K973589 | LIQUID LDH-L REAGENT SET | CFJ | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| August 1, 1997 | K971309 | UREA | CDQ | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| August 1, 1997 | K970664 | GLUCOSE REAGENT | CFR | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| June 20, 1997 | K971072 | CHOLESTEROL REAGENT | CHH | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| February 18, 1997 | K965134 | ALT/SGPT | CKA | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| February 4, 1997 | K964914 | ALKALINE PHOSPHATASE | CJE | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| January 17, 1997 | K965126 | AST/SGOT | CIT | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| May 20, 1996 | K960708 | BENZODIAZEPINE SERUM TOX EIA TEST | JXM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| May 6, 1996 | K960664 | BARBITURATE SERUM TOX EIA ASSAY | DIS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| March 13, 1996 | K955781 | ALBUMIN | CIX | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| March 12, 1996 | K955936 | TOTAL PROTEIN REAGENT | CEK | Substantially Equivalent | Derma Media Lab., Inc. | accessdata.fda.gov |
| March 11, 1996 | K955928 | BARBITURATE EIA ESSAY (MODIFICATION) | DIS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| November 4, 1994 | K943998 | CANNABINOID EIA ASSAY | LDJ | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| September 9, 1994 | K943414 | PROPOXPHENE EIA TEST | JXN | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| January 31, 1994 | K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | JFJ | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
| January 26, 1994 | K934667 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| January 13, 1994 | K934891 | AMPHETAMINES EIA ASSAY MODIFICATION | DKZ | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| December 29, 1993 | K935320 | PHENCYCLIDINE EIA ASSAY | LCM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| August 5, 1993 | K930529 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| January 21, 1993 | K923783 | ETHYL ALCOHOL ASSAY | DMT | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| March 13, 1987 | K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT | CDT | Substantially Equivalent | Intersect Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2020 | 85259 | Class II | Terminated | SPICE (JWH-018) CC443 | Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only. | accessdata.fda.gov |
| January 20, 2020 | 85229 | Class II | Terminated | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes | accessdata.fda.gov |
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Updated December 13, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.