Alkaline Phosphatase-Rate
FDA 510(k) K833744 · Seragen Diagnostics, Inc.
510(k) numberK833744
Submission
- Device name
- Alkaline Phosphatase-Rate
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- October 26, 1983
- Decision date
- January 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251074 | Tru Liver Health Test PanelCJE · Traditional | Truvian Health | 12/19/2025SE |
| K240468 | Alkaline PhosphataseCJE · Special | Abbott Laboratories Diagnostics Division | 10/16/2024SE |
| K223317 | Alkaline Phosphatase2CJE · Traditional | Abbott Ireland Diagnostics Division | 07/21/2023SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | Horiba Abx SAS | 08/30/2019SE |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…CJE · Traditional | Lite-On Technology Corp. H.S.P.B. | 01/25/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | Roche Diagnostics Operations (Rdo) | 05/10/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | Randox Laboratories Limited | 04/21/2017SE |
| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 08/15/2013SE |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/22/2013SE |
| 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 |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
Questions and answers
When was Alkaline Phosphatase-Rate cleared by the FDA?
Alkaline Phosphatase-Rate (K833744) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 79 days after the submission was received.
What is the product code of K833744?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.