TEST KIT, IIF-AMA
FDA 510(k) clearance K790295 · decided 1979-05-25
Clearance details
- K-number
- K790295
- Device name
- TEST KIT, IIF-AMA
- Applicant
- Medica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-09
- Decision date
- 1979-05-25
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.