510(k) K970093
- Device
- TYROSINE 50-HOUR REAGENT KIT
- Applicant
- ASTORIA-PACIFIC,INC.
- 510(k) number
- K970093
- Product code
- CDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-19
- Date received
- 1997-01-10
- Regulation
- 862.1730
- Classification name
- 1-nitroso-2-naphthol (fluorometric), Free Tyrosine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND L PAVITT
- Address
- 14600 SE 82nd Dr. Clackamas OR US 97015 97015
FDA Registration Numbers#
- 3050015
Source Documents#
Legacy Summary#
summary
FDA Review#
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