The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Urine Proteins Reagent.
| Device ID | K885053 |
| 510k Number | K885053 |
| Device Name: | BIOTROL URINE PROTEINS REAGENT |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-07 |
| Decision Date | 1989-01-30 |