Data / Medical devices / United States / Phamatech Inc.
Phamatech Inc.: FDA-registered device maker in San Diego, CA, United States, 16 510(k) clearances
Phamatech Inc. is registered with the FDA (registration 2031229) in San Diego, CA, United States. It lists 19 device types. The FDA files 16 510(k) clearances under its listings, the newest dated December 7, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031229
- FEI number
- 3000719950
- Address
- 15175 Innovation Dr, San Diego, CA, United States, 92128
- Owner or operator
- PHAMATECH INC. (9026390)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- June 8, 1998
- Registered through
- 2026
- Brand names listed
- AT HOME QUICKCUP PREGNANCY TEST, At Home, ING TEST, MOMENTS MENOPAUSE CHECK, OVUCARD LH TEST, Phamatech's COVID-19 IgG / IgM Rapid Test, QUICKSCREEN HOME DRUG TEST SYSTEM, QUICKSCREEN ONE STEP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Barbiturate | DIS | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Benzodiazepine | JXM | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Methadone | DJR | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fluorometry, Morphine | DJJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | MVO | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thin Layer Chromatography, Amphetamine | DIT | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Thin Layer Chromatography, Cocaine | DMN | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
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 7, 2007 | K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | DIS | Substantially Equivalent | Phamatech, Inc. | accessdata.fda.gov |
| December 7, 2007 | K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | DIS | Substantially Equivalent | Phamatech, Inc. | accessdata.fda.gov |
| February 7, 2005 | K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | DJG | Substantially Equivalent | Phamatech, Inc. | accessdata.fda.gov |
| December 29, 2004 | K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | JXM | Substantially Equivalent | Phamatech, Inc. | accessdata.fda.gov |
| May 20, 2004 | K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | CGJ | Substantially Equivalent | Phamatech, Inc. | accessdata.fda.gov |
| February 12, 2001 | K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 | MVO | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| November 8, 1999 | K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 | LCX | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| March 22, 1999 | K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | CEP | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| February 5, 1999 | K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 | DJR | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| February 4, 1998 | K974582 | QUICKSCREEN ONE STEP PCP SCREENING TEST | LCM | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| January 26, 1998 | K974615 | QUICKSTICK PRO HCG TEST | JHI | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| September 25, 1997 | K973122 | QUICKSCREEN ONE STEP THC SCREENING TEST | LDJ | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| September 2, 1997 | K972556 | QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) | LAF | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| August 20, 1997 | K972619 | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) | DJG | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| August 20, 1997 | K972577 | QUICK SCREEN ONE STEP AMPHETAMINE TEST | DIT | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| August 8, 1997 | K972618 | QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) | DMN | Substantially Equivalent | Phamatech | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Immunoassay, Benzodiazepine
- All makers of Enzyme Immunoassay, Opiates
- All makers of Radioimmunoassay, Luteinizing Hormone
- All makers of Enzyme Immunoassay, Methadone
- All makers of Enzyme Immunoassay, Phencyclidine
Updated December 7, 2007. 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.