The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Supplementary Reagents For Enzygnost/tmb.
| Device ID | K920416 |
| 510k Number | K920416 |
| Device Name: | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-04-08 |