Atac Pak Alp Reagent Kit
FDA 510(k) K002285 · Elan Diagnostics
510(k) numberK002285
Submission
- Device name
- Atac Pak Alp Reagent Kit
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- July 26, 2000
- Decision date
- September 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Alfa Wassermann
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
Questions and answers
When was Atac Pak Alp Reagent Kit cleared by the FDA?
Atac Pak Alp Reagent Kit (K002285) received a 510(k) decision of Substantially Equivalent on September 26, 2000, 62 days after the submission was received.
What is the product code of K002285?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.