The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for H 10 Or Hematil 10 Blood Cell & Platelet Counter.
| Device ID | K883177 |
| 510k Number | K883177 |
| Device Name: | H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER |
| Classification | Counter, Differential Cell |
| Applicant | TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Contact | Robert Cogan |
| Correspondent | Robert Cogan TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-27 |
| Decision Date | 1988-11-30 |