The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Anti-dnase B Reagent System.
Device ID | K790997 |
510k Number | K790997 |
Device Name: | ANTI-DNASE B REAGENT SYSTEM |
Classification | Antideoxyribonuclease, Streptococcus Spp. |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTR |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-29 |
Decision Date | 1979-07-24 |