The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Uric Acid (tptz) Colorinmetric.
| Device ID | K810088 |
| 510k Number | K810088 |
| Device Name: | URIC ACID (TPTZ) COLORINMETRIC |
| Classification | Acid, Uric, Phosphotungstate Reduction |
| Applicant | BIO-ANALYTICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDH |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-01-28 |