TYROSINE 50-HOUR REAGENT KIT
FDA 510(k) clearance K970093 · decided 1998-03-19
Clearance details
- K-number
- K970093
- Device name
- TYROSINE 50-HOUR REAGENT KIT
- Applicant
- Astoria-Pacific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-10
- Decision date
- 1998-03-19
- Days to decision
- 433 days
- Clearance type
- Traditional
- Product code
- CDR
- Device class
- 1
- Regulation number
- 862.1730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.