The following data is part of a premarket notification filed by International Enzymes, Inc. with the FDA for Linical Protein Vi Calibration Verifiers Levels A-e.
| Device ID | K944513 |
| 510k Number | K944513 |
| Device Name: | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | INTERNATIONAL ENZYMES, INC. 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Contact | Teva C Rothwell |
| Correspondent | Teva C Rothwell INTERNATIONAL ENZYMES, INC. 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1994-12-02 |