ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
FDA 510(k) clearance K953826 · decided 1995-12-14
Clearance details
- K-number
- K953826
- Device name
- ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
- Applicant
- Pyramid Biological Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-15
- Decision date
- 1995-12-14
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- GOM
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Van Nuys, CA, 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 |
|---|---|---|
| ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (K954515) | Pyramid Biological Corp. | 1995-12-20 |
Recalls involving this device
No recalls on record reference this clearance.