The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Opti-check Plus Multi-analyte Control, Model Hc7009.
| Device ID | K001632 |
| 510k Number | K001632 |
| Device Name: | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2000-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894472000114 | K001632 | 000 |