RESPIRACULT-STREP DEEP BED CULTURE PAD— 510(k) K821659
Substantially EquivalentOrion Diagnostica, Inc.
FDA 510(k) clearance K821659 for RESPIRACULT-STREP DEEP BED CULTURE PAD, Substantially Equivalent on 1982-08-05. Applicant: Orion Diagnostica, Inc.. Device class: 1.
Clearance details
- Applicant
- Orion Diagnostica, Inc.
- Product code
- Code JSH
- Device class
- Class 1
- Regulation
- 21 CFR 866.2320
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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