The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Hemat 12.
| Device ID | K884006 |
| 510k Number | K884006 |
| Device Name: | HEMAT 12 |
| Classification | Counter, Differential Cell |
| Applicant | TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham, MA 02192 |
| Contact | Robert P Cogan |
| Correspondent | Robert P Cogan TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham, MA 02192 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-21 |
| Decision Date | 1988-12-05 |