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 For Beckman Array Protein System.
| Device ID | K953927 |
| 510k Number | K953927 |
| Device Name: | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | INTERNATIONAL ENZYMES, INC. 772-F NORTH TWIN OAKS VALLEY, RD. San Marcos, CA 92069 |
| Contact | Teva C Rothwell |
| Correspondent | Teva C Rothwell INTERNATIONAL ENZYMES, INC. 772-F NORTH TWIN OAKS VALLEY, RD. San Marcos, CA 92069 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-09-15 |