The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Coomassie Blue Total Protein Assay Kit.
| Device ID | K890618 |
| 510k Number | K890618 |
| Device Name: | COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT |
| Classification | Biuret (colorimetric), Total Protein |
| 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 | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-07 |
| Decision Date | 1989-05-22 |