SALMONELLA IFA*
FDA 510(k) clearance K885114 · decided 1989-08-15
Clearance details
- K-number
- K885114
- Device name
- SALMONELLA IFA*
- Applicant
- Investigacion Farmaceutica S.A. DE C.V.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-12
- Decision date
- 1989-08-15
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- GHC
- Device class
- 1
- Regulation number
- 864.6700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mexico, MX
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.