RAPID YEAST PLUS SYSTEM
FDA 510(k) clearance K943621 · decided 1995-01-27
Clearance details
- K-number
- K943621
- Device name
- RAPID YEAST PLUS SYSTEM
- Applicant
- Innovative Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-27
- Decision date
- 1995-01-27
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- JXB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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