Alkaline Phosphatase Indolyl Blue Reagent
FDA 510(k) K870890 · Helena Laboratories
510(k) numberK870890
Submission
- Device name
- Alkaline Phosphatase Indolyl Blue Reagent
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 5, 1987
- Decision date
- June 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Alkaline Phosphatase Indolyl Blue Reagent cleared by the FDA?
Alkaline Phosphatase Indolyl Blue Reagent (K870890) received a 510(k) decision of Substantially Equivalent on June 1, 1987, 88 days after the submission was received.
What is the product code of K870890?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.