The following data is part of a premarket notification filed by Bio-chem Laboratory Systems, Inc. with the FDA for Autobead(tm) T4 Enzyme Immunoassay Test Kit.
| Device ID | K926563 |
| 510k Number | K926563 |
| Device Name: | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood, NJ 08701 |
| Contact | Jon D Turpen |
| Correspondent | Jon D Turpen BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood, NJ 08701 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-03-18 |