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 | K993837 |
| 510k Number | K993837 |
| Device Name: | AVL OPTI CRITICAL CARE ANALYZER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AVL SCIENTIFIC CORP. 235 HEMBREE PARK DR. Roswell, GA 30076 |
| Contact | Randy Byrd |
| Correspondent | Randy Byrd AVL SCIENTIFIC CORP. 235 HEMBREE PARK DR. Roswell, GA 30076 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 1999-12-16 |
| Summary: | summary |