FIAX TEST KIT FOR MUMPS-G ANTIBODIES
FDA 510(k) clearance K872733 · decided 1987-10-06
Clearance details
- K-number
- K872733
- Device name
- FIAX TEST KIT FOR MUMPS-G ANTIBODIES
- Applicant
- Whittaker Bioproducts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-09
- Decision date
- 1987-10-06
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GRB
- Device class
- 1
- Regulation number
- 866.3380
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walkersville, MD, US
- 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 |
|---|---|---|
| MUMPS CF ANTIGEN AND CONTROL ANTIGEN (K872699) | Sita, Inc. | 1987-09-18 |
Recalls involving this device
No recalls on record reference this clearance.