MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
FDA 510(k) clearance K905306 · decided 1991-06-17
Clearance details
- K-number
- K905306
- Device name
- MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
- Applicant
- Virion (U.S.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-28
- Decision date
- 1991-06-17
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- GRC
- Device class
- 1
- Regulation number
- 866.3380
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morristown, NJ, 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 COMPLEMENT FIXATION & HEMAGGLU (K832873) | Hazleton Dutchland, Inc. | 1983-12-27 |
| MUMPS S & V ANTIGENS & CONTROLS (K802933) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.