Data / Medical devices / United States / Verichem Laboratories, Inc.
Verichem Laboratories, Inc.: FDA-registered device maker in Providence, RI, United States, 9 510(k) clearances
Verichem Laboratories, Inc. is registered with the FDA (registration 1221645) in Providence, RI, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 28, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221645
- Address
- 90 Narragansett Ave., Providence, RI, United States, 02907
- Owner or operator
- VERICHEM LABORATORIES, INC. (1221645)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 28, 2007
- Registered through
- 2026
- Brand names listed
- Ammonia/Iron Standard Kit, Ammonia/Iron Standard, Level (F), BR2 Bilirubin Calibrator, Bilirubin Standard Kit, Bilirubin Standard Level (F), Carbon Dioxide Standard Kit, Carbon Dioxide Standard Kit, Level (F), Carbon Dioxide Standard, 30 mmol/L and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Calibrators, Ethyl Alcohol | DNN | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Controls (Assayed And Unassayed) | JJT | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 28, 2012 | K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| December 19, 1997 | K974290 | MICROPROTEIN STANDARD KIT | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| July 23, 1997 | K972333 | AMMONIA/IRON STANDARD KIT | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| January 13, 1993 | K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION | JIS | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| March 29, 1990 | K901113 | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD | JIS | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| October 25, 1988 | K882059 | BILIRUBIN STANDARD | JIT | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| August 4, 1988 | K882117 | ETHYL ALCOHOL STANDARD | DNN | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| June 24, 1988 | K882116 | TOTAL PROTEIN/ALBUMIN STANDARD | JIX | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
| February 18, 1988 | K880266 | MULTI-ENZYME LINEARITY SOLUTION | JJT | Substantially Equivalent | Verichem Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Primary
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Calibrator, Secondary
- All makers of Calibrators, Ethyl Alcohol
- All makers of Enzyme Controls (Assayed And Unassayed)
Updated March 28, 2012. 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.