The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Trademark Blood Gas/electrolyte/glucose, Lactate, Bun And Creatinine Control.
| Device ID | K972868 |
| 510k Number | K972868 |
| Device Name: | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
| Contact | Bruce R Williams |
| Correspondent | Bruce R Williams BIONOSTICS, INC. 2 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 | 1997-08-04 |
| Decision Date | 1997-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749001088 | K972868 | 000 |
| 00054749001071 | K972868 | 000 |
| 00054749001064 | K972868 | 000 |
| 00054749001057 | K972868 | 000 |
| 00054749000685 | K972868 | 000 |
| 00054749000661 | K972868 | 000 |
| 00054749000647 | K972868 | 000 |
| 00054749000562 | K972868 | 000 |
| 00054749000463 | K972868 | 000 |