The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Analyzer: Stat Profile Plus 10 Analyzer.
| Device ID | K931373 |
| 510k Number | K931373 |
| Device Name: | ANALYZER: STAT PROFILE PLUS 10 ANALYZER |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul Macdonald |
| Correspondent | Paul Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-18 |
| Decision Date | 1993-06-15 |