The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Max Plus Glocose And B-ketone Control Solution-mid, High.
| Device ID | K101633 |
| 510k Number | K101633 |
| Device Name: | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480496407 | K101633 | 000 |