The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Ldl-c Reagent, Ldl-c Calibrator, Ldl-c Controls.
| Device ID | K991733 |
| 510k Number | K991733 |
| Device Name: | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Steven Dalessio |
| Correspondent | Steven Dalessio SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | MRR |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-21 |
| Decision Date | 1999-07-13 |
| Summary: | summary |