The following data is part of a premarket notification filed by International Enzymes, Inc. with the FDA for Liquid Immunology Control Level I, Ii, Iii.
| Device ID | K963085 |
| 510k Number | K963085 |
| Device Name: | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-08 |
| Decision Date | 1996-08-20 |