The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Total Iron, Uibc/tibc Assay Kit.
| Device ID | K890573 |
| 510k Number | K890573 |
| Device Name: | KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
| Contact | Som, Ph.d. |
| Correspondent | Som, Ph.d. KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-24 |