LEGIONELLA CYE AGAR BASE & BCYE SUPPL
FDA 510(k) clearance K831469 · decided 1983-06-08
Clearance details
- K-number
- K831469
- Device name
- LEGIONELLA CYE AGAR BASE & BCYE SUPPL
- Applicant
- Oxoid U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-06
- Decision date
- 1983-06-08
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- JSK
- Device class
- 1
- Regulation number
- 866.2450
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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