IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
FDA 510(k) clearance K885113 · decided 1989-08-15
Clearance details
- K-number
- K885113
- Device name
- IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
- 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
- GSN
- Device class
- 2
- Regulation number
- 866.3085
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mexico, MX
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM (K952145) | Sa Scientific, Inc. | 1995-07-18 |
| NEGATIVE CONTROL SERUM FOR CF RO ID (K791385) | Immuno-Mycologics, Inc. | 1979-08-16 |
Recalls involving this device
No recalls on record reference this clearance.