The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Chema Chol Cholesterol System.
| Device ID | K904031 |
| 510k Number | K904031 |
| Device Name: | CHEMA CHOL CHOLESTEROL SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Contact | Albert Blanco |
| Correspondent | Albert Blanco TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston, TX 77036 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-31 |
| Decision Date | 1991-03-11 |