The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Pyrogallol Red Microprotein Assay Kit.
| Device ID | K896440 |
| 510k Number | K896440 |
| Device Name: | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | KENLOR INDUSTRIES, INC. 9582 HAMLITON AVE. SUITE 251 Huntington Beach, CA 92646 |
| Contact | Som, Ph.d. |
| Correspondent | Som, Ph.d. KENLOR INDUSTRIES, INC. 9582 HAMLITON AVE. SUITE 251 Huntington Beach, CA 92646 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-09 |
| Decision Date | 1990-02-16 |