Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, Abtrol
FDA 510(k) K073191 · Thermofisher Scientific OY
510(k) numberK073191
Submission
- Device name
- Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, Abtrol
- Applicant
- Thermofisher Scientific OY
Vantaa, FI - Received
- November 13, 2007
- Decision date
- February 28, 2008
- 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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| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 08/15/2013SE |
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| K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional | Alfa Wassermann | 07/12/2012SE |
More from Alfa Wassermann
| 510(k) | Device | Decision |
|---|---|---|
| K110035 | IndikoJJE · Traditional | 06/28/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | 05/29/2008SE |
| K073612 | Uric Acid (Aox), Scal, Nortrol, AbtrolJIX · Traditional | 05/23/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | 02/28/2008SE |
| K070824 | Creatinine (Enzymatic)JFY · Traditional | 12/03/2007SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | 10/05/2007SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | 10/03/2007SE |
Questions and answers
When was Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, Abtrol cleared by the FDA?
Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, Abtrol (K073191) received a 510(k) decision of Substantially Equivalent on February 28, 2008, 107 days after the submission was received.
What is the product code of K073191?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.