The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Clinistat Triglycerides Reagent Test.
| Device ID | K885134 |
| 510k Number | K885134 |
| Device Name: | CLINISTAT TRIGLYCERIDES REAGENT TEST |
| Classification | Colorimetric Method, Triglycerides |
| Applicant | HERAEUS KULZER, INC. DIAGNOSTICS DIVISION P.O. BOX 70 Elkhart, IN 46515 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. DIAGNOSTICS DIVISION P.O. BOX 70 Elkhart, IN 46515 |
| Product Code | JGY |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-02-10 |