The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Enzac Uric Acid 100-test Kit.
| Device ID | K772082 |
| 510k Number | K772082 |
| Device Name: | ENZAC URIC ACID 100-TEST KIT |
| Classification | Acid, Uric, Phosphotungstate Reduction |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | CDH |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-03 |
| Decision Date | 1977-11-28 |