N-ASSAY TIA MULTI V-NL
FDA 510(k) clearance K933973 · decided 1994-01-28
Clearance details
- K-number
- K933973
- Device name
- N-ASSAY TIA MULTI V-NL
- Applicant
- Crestat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-13
- Decision date
- 1994-01-28
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Thousand Oaks, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.