ENZYGNOST + ANTI-CMV IGG TEST
FDA 510(k) clearance K852478 · decided 1985-09-16
Clearance details
- K-number
- K852478
- Device name
- ENZYGNOST + ANTI-CMV IGG TEST
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-11
- Decision date
- 1985-09-16
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- LFZ
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- La Jolla, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |