The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Padac.
Device ID | K812458 |
510k Number | K812458 |
Device Name: | PADAC |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-31 |
Decision Date | 1981-09-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PADAC 73343898 1246706 Dead/Cancelled |
Calbiochem-Behring Corp. 1981-12-30 |