The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Blood Gads, Electrolyte, Glucose, Latate And Bun Quality Control Product.
| Device ID | K943754 |
| 510k Number | K943754 |
| Device Name: | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Contact | Bruce R Williams |
| Correspondent | Bruce R Williams BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851290002550 | K943754 | 000 |