The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Triglycerides Reagent.
| Device ID | K954187 |
| 510k Number | K954187 |
| Device Name: | TRIGLYCERIDES REAGENT |
| Classification | Colorimetric Method, Triglycerides |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Robert J Paquet |
| Correspondent | Robert J Paquet SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | JGY |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-10-23 |