The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Opti Critical Care Analyzer.
| Device ID | K974784 |
| 510k Number | K974784 |
| Device Name: | AVL OPTI CRITICAL CARE ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
| Contact | Randy Byrd |
| Correspondent | Mike Carrasquillo AVL SCIENTIFIC CORP. 235 Hembree Park Drive Roswell, GA 30076 |
| Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894472000244 | K974784 | 000 |
| 00894472000237 | K974784 | 000 |