The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Clinical Chemistry System.
| Device ID | K930104 |
| 510k Number | K930104 |
| Device Name: | ACE CLINICAL CHEMISTRY SYSTEM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Mark A Spain |
| Correspondent | Mark A Spain SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | JIX |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1993-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006402 | K930104 | 000 |
| 00857969006396 | K930104 | 000 |