The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Hematil 18 (h-18).
| Device ID | K953643 |
| 510k Number | K953643 |
| Device Name: | HEMATIL 18 (H-18) |
| Classification | Counter, Differential Cell |
| Applicant | TEXAS INTL. LABORATORIES, INC. 5 RAIN HOLLOW Houston, TX 77024 |
| Contact | Yves Lebihan |
| Correspondent | Yves Lebihan TEXAS INTL. LABORATORIES, INC. 5 RAIN HOLLOW Houston, TX 77024 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1996-03-22 |