The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Triglyerides Test Kit.
| Device ID | K874584 |
| 510k Number | K874584 |
| Device Name: | TRIGLYERIDES TEST KIT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. GILFORD SYSTEMS 132 ARTINO STREET Oberlin, OH 44074 |
| Contact | Craig H Reason |
| Correspondent | Craig H Reason CIBA CORNING DIAGNOSTICS CORP. GILFORD SYSTEMS 132 ARTINO STREET Oberlin, OH 44074 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-01-21 |