Data / Medical devices / United States / Quantimetrix Corp.
Quantimetrix Corp.: FDA-registered device maker in Redondo Beach, CA, United States, 15 510(k) clearances
Quantimetrix Corp. is registered with the FDA (registration 2020715) in Redondo Beach, CA, United States. It lists 7 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 10, 2015. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2020715
- Address
- 2005 Manhattan Beach Blvd, Redondo Beach, CA, United States, 90278
- Owner or operator
- QUANTIMETRIX CORP. (2020715)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- July 19, 1979
- Registered through
- 2026
- Brand names listed
- AUTION CHECK Plus, Ammonia/Alcohol Control, Aution Check Plus, Bilirubin Control Pediatric, CHROMASCOPICS Urinalysis Control with Microscopics, 1540-01, Complete D 25-OH Vitamin D Control, Dip&Spin Urinalysis Dipstick Microscopics Control, Dipper POCT Urinalysis Dipstick Control, 1400-01, 1400-02 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biuret (Colorimetric), Total Protein | CEK | 2 | Manufacturer | accessdata.fda.gov |
| Electrolyte Controls (Assayed And Unassayed) | JJR | 1 | Manufacturer | accessdata.fda.gov |
| Electrophoretic Separation, Lipoproteins | JHO | 1 | Manufacturer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Contract manufacturer, Manufacturer, Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| April 10, 2015 | K142262 | AUTION CHECK PLUS | JJW | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| May 10, 2012 | K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | JJX | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| May 12, 2011 | K103744 | DROPPER A1C DIABETES CONTROL | JJX | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| March 8, 2002 | K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| July 25, 2001 | K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970862 | SPINALSCOPICS | JJY | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| October 4, 1994 | K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | JJR | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| March 1, 1993 | K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL | JJY | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| September 25, 1991 | K913346 | QUANTIMETRIX AMMONIA CONTROLS | JJX | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| January 25, 1991 | K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | CEK | Substantially Equivalent | Quantitative Medicine, Inc. | accessdata.fda.gov |
| January 21, 1988 | K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL | JJW | Substantially Equivalent | Quantimetrix Medical Industries | accessdata.fda.gov |
| May 23, 1986 | K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID | JJY | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| December 19, 1985 | K853932 | QUANTTEST TOTAL PROTEIN ASSAY | CEK | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| August 12, 1983 | K831526 | URINE TOTAL PROTEIN CONTROL | JJW | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| July 18, 1983 | K831527 | SPINAL FLUID TOTAL PROTEIN CONTROL | JJX | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 21, 2017 | 80179 | Class III | Terminated | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by t | The kits contained an incorrect lot of Dropper Plus Level 1 vials | accessdata.fda.gov |
| June 1, 2007 | 48190 | Not yet classified | Terminated | Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | accessdata.fda.gov |
Compare with other makers
- All makers of Urinalysis Controls (Assayed And Unassayed)
- All makers of Biuret (Colorimetric), Total Protein
- All makers of Mixture, Hematology Quality Control
- All makers of Electrolyte Controls (Assayed And Unassayed)
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Electrophoretic Separation, Lipoproteins
Updated April 10, 2015. 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.