The following data is part of a premarket notification filed by Triton Biosciences, Inc. with the FDA for Mak-6 Monoclonal Anti-cytokeratin Cocktail.
| Device ID | K881259 |
| 510k Number | K881259 |
| Device Name: | MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL |
| Classification | Cytokeratins |
| Applicant | TRITON BIOSCIENCES, INC. 1501 HARBOR BAY PKWY. Alameda, CA 94501 |
| Contact | Barbara L Westrick |
| Correspondent | Barbara L Westrick TRITON BIOSCIENCES, INC. 1501 HARBOR BAY PKWY. Alameda, CA 94501 |
| Product Code | LYE |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-23 |
| Decision Date | 1988-10-12 |