TRANSYSTEM LIQUID AMIES MEDIUM
FDA 510(k) clearance K924328 · decided 1992-12-24
Clearance details
- K-number
- K924328
- Device name
- TRANSYSTEM LIQUID AMIES MEDIUM
- Applicant
- Pro-Lab Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1992-08-27
- Decision date
- 1992-12-24
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LIO
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.