The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Analyzer: Nova 10 Crt Analyzer & Quali Cont Mater.
| Device ID | K923806 |
| 510k Number | K923806 |
| Device Name: | ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Mcdonald |
| Correspondent | Mcdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-29 |
| Decision Date | 1992-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480539644 | K923806 | 000 |
| 00385480131988 | K923806 | 000 |
| 00385480141789 | K923806 | 000 |
| 00385480146081 | K923806 | 000 |
| 00385480146173 | K923806 | 000 |
| 00385480146180 | K923806 | 000 |
| 00385480147125 | K923806 | 000 |
| 10385480152119 | K923806 | 000 |
| 10385480152126 | K923806 | 000 |
| 10385480152799 | K923806 | 000 |
| 00385480161381 | K923806 | 000 |
| 10385480539637 | K923806 | 000 |
| 00385480131971 | K923806 | 000 |