BACTIGEN GROUP B STREPTOCOCCUS TEST— 510(k) K850772
Substantially EquivalentArmkel, LLC
FDA 510(k) clearance K850772 for BACTIGEN GROUP B STREPTOCOCCUS TEST, Substantially Equivalent on 1985-05-29. Applicant: Armkel, LLC. Device class: 1.
Clearance details
- Applicant
- Armkel, LLC
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranbury, NJ, US
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