The following data is part of a premarket notification filed by Verified Medical Research, Inc. with the FDA for Audit Automated Blood Chemistry Analyzer.
| Device ID | K854028 |
| 510k Number | K854028 |
| Device Name: | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER |
| Classification | Calibrator, Surrogate |
| Applicant | VERIFIED MEDICAL RESEARCH, INC. 124 E. HARVARD TEMPE, AZ 85283 |
| Contact | GARY W SHIRES |
| Correspondent | GARY W SHIRES VERIFIED MEDICAL RESEARCH, INC. 124 E. HARVARD TEMPE, AZ 85283 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-01 |
| Decision Date | 1985-12-02 |