Tyrosine 50-HOUR Reagent Kit
FDA 510(k) K970093 · Astoria-Pacific, Inc.
510(k) numberK970093
Submission
- Device name
- Tyrosine 50-HOUR Reagent Kit
- Applicant
- Astoria-Pacific, Inc.
Clackamas, OR, US - Received
- January 10, 1997
- Decision date
- March 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDR – 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1730
- Specialty
- Clinical Chemistry
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Questions and answers
When was Tyrosine 50-HOUR Reagent Kit cleared by the FDA?
Tyrosine 50-HOUR Reagent Kit (K970093) received a 510(k) decision of Substantially Equivalent on March 19, 1998, 433 days after the submission was received.
What is the product code of K970093?
The FDA product code is CDR – 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine, a Class I (low risk) device regulated under 21 CFR 862.1730.