The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rapi/tex Aso Standard Serum.
Device ID | K800642 |
510k Number | K800642 |
Device Name: | RAPI/TEX ASO STANDARD SERUM |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-24 |
Decision Date | 1980-04-24 |