The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Plt-4 Platelet Analyzer.
| Device ID | K853722 |
| 510k Number | K853722 |
| Device Name: | PLT-4 PLATELET ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Contact | Robert P Cogan |
| Correspondent | Robert P Cogan TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1986-01-17 |