Coulter Amylase Reagent
FDA 510(k) K900230 · Coulter Corp.
510(k) numberK900230
Submission
- Device name
- Coulter Amylase Reagent
- Applicant
- Coulter Corp.
Hialeah, FL, US - Received
- January 17, 1990
- Decision date
- April 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFJ – Catalytic Methods, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210633 | Amylase2JFJ · Traditional | Abbott Ireland Diagnostics Division | 05/26/2022SE |
| K191454 | Atellica CH Amylase_2 (AMY_2)JFJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2019SE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT…JFJ · Traditional | Biosystems S.A. | 05/02/2019SE |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/09/2013SE |
| K122858 | Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional | Elitechgroup | 10/03/2012SE |
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional | Beckman Coulter, Inc. | 10/16/2009SE |
| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional | Medica Corp. | 11/17/2008SE |
| K070064 | Amylase Eps ReagentJFJ · Traditional | Thermo Fisher Scientific | 05/22/2007SE |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional | Horiba Abx | 10/02/2006SE |
| K051447 | Sentinel Pancreatic AmylaseJFJ · Traditional | Sentinel Ch. Srl | 01/26/2006SE |
More from Sentinel Ch. Srl
| 510(k) | Device | Decision |
|---|---|---|
| K993356 | Coulter Hematology Analyzers with Irf & MRV AnalysesGKZ · Traditional | 04/20/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | 05/11/1999SE |
| K990327 | Reticone System for Epics XL Flow Cytometry SystemsGKZ · Traditional | 04/26/1999SE |
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…GKZ · Traditional | 04/13/1999SE |
| K990352 | Coulter Ac T Diff 2 AnalyzerGKZ · Traditional | 04/01/1999SE |
| K984216 | Immuno-Trol Control CellsJPK · Traditional | 03/16/1999SE |
| K982167 | Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/09/1998SE |
| K982166 | Cyto-Stat Trichrome CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/05/1998SE |
| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | 09/24/1998SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | 10/29/1997SE |
Questions and answers
When was Coulter Amylase Reagent cleared by the FDA?
Coulter Amylase Reagent (K900230) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 76 days after the submission was received.
What is the product code of K900230?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.