Alkaline Phosphatase Liquid Reagent
FDA 510(k) K011599 · Jas Diagnostics, Inc.
510(k) numberK011599
Submission
- Device name
- Alkaline Phosphatase Liquid Reagent
- Applicant
- Jas Diagnostics, Inc.
Miami, FL, US - Received
- May 24, 2001
- Decision date
- July 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
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| K020454 | Chemistry CalibratorJIT · Traditional | 04/08/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | 12/21/2001SE |
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Questions and answers
When was Alkaline Phosphatase Liquid Reagent cleared by the FDA?
Alkaline Phosphatase Liquid Reagent (K011599) received a 510(k) decision of Substantially Equivalent on July 20, 2001, 57 days after the submission was received.
What is the product code of K011599?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.