Anti-Dnase B Reagent System
FDA 510(k) K790997 · Calbiochem-Behring Corp.
510(k) numberK790997
Submission
- Device name
- Anti-Dnase B Reagent System
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- May 29, 1979
- Decision date
- July 24, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTR – Antideoxyribonuclease, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3720
- Specialty
- Microbiology
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Questions and answers
When was Anti-Dnase B Reagent System cleared by the FDA?
Anti-Dnase B Reagent System (K790997) received a 510(k) decision of Substantially Equivalent on July 24, 1979, 56 days after the submission was received.
What is the product code of K790997?
The FDA product code is GTR – Antideoxyribonuclease, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3720.