Iq Alkaline Phosphatase
FDA 510(k) K880344 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK880344
Submission
- Device name
- Iq Alkaline Phosphatase
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- January 26, 1988
- Decision date
- March 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJK – Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Iq Alkaline Phosphatase cleared by the FDA?
Iq Alkaline Phosphatase (K880344) received a 510(k) decision of Substantially Equivalent on March 1, 1988, 35 days after the submission was received.
What is the product code of K880344?
The FDA product code is CJK – Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.