Spife 2000/3000 Alp 40, 20; Models 3345 and 3346
FDA 510(k) K020625 · Helena Laboratories
510(k) numberK020625
Submission
- Device name
- Spife 2000/3000 Alp 40, 20; Models 3345 and 3346
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 26, 2002
- Decision date
- May 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
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Questions and answers
When was Spife 2000/3000 Alp 40, 20; Models 3345 and 3346 cleared by the FDA?
Spife 2000/3000 Alp 40, 20; Models 3345 and 3346 (K020625) received a 510(k) decision of Substantially Equivalent on May 6, 2002, 69 days after the submission was received.
What is the product code of K020625?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.