The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Series 810 Platelet Analyzer.
| Device ID | K803128 |
| 510k Number | K803128 |
| Device Name: | SERIES 810 PLATELET ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | J.T. BAKER CHEMICAL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-12 |
| Decision Date | 1981-04-03 |