GAP-IGG
FDA 510(k) clearance K900343 · decided 1991-08-22
Clearance details
- K-number
- K900343
- Device name
- GAP-IGG
- Applicant
- Biomerica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-23
- Decision date
- 1991-08-22
- Days to decision
- 576 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.