VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
FDA 510(k) clearance K900688 · decided 1990-05-15
Clearance details
- K-number
- K900688
- Device name
- VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
- Applicant
- Clinical Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-13
- Decision date
- 1990-05-15
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LFY
- Device class
- 2
- Regulation number
- 866.3900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Whippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in recall (Z-0572-05) | Diasorin Inc. | 2005-03-08 |