The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 12 Analyzer, Modification.
| Device ID | K924743 |
| 510k Number | K924743 |
| Device Name: | NOVA 12 ANALYZER, MODIFICATION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-14 |
| Decision Date | 1992-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480165013 | K924743 | 000 |
| 00385480156509 | K924743 | 000 |
| 00385480147156 | K924743 | 000 |
| 00385480139854 | K924743 | 000 |
| 00385480131940 | K924743 | 000 |
| 00385480131926 | K924743 | 000 |
| 10385480001257 | K924743 | 000 |