The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Hdl-c Reagent.
| Device ID | K971526 |
| 510k Number | K971526 |
| Device Name: | ACE HDL-C REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Steve Dalessio |
| Correspondent | Steve Dalessio SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | LBS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-05-21 |
| Summary: | summary |