Stanbio Alpha-Amylase Test Set, Catalog 0180-715
FDA 510(k) K870746 · Stanbio Laboratory
510(k) numberK870746
Submission
- Device name
- Stanbio Alpha-Amylase Test Set, Catalog 0180-715
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- February 25, 1987
- Decision date
- June 1, 1987
- 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
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| 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 |
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|---|---|---|
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | 06/10/2009SE |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | 07/18/2008SE |
| K050283 | Creatinine LiquicolorJFY · Traditional | 06/30/2005SE |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | 06/30/2005SE |
| K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerJJE · Traditional | 03/14/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | 10/14/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | 10/24/2003SE |
| K020378 | Qupid Plus E.R.JHI · Traditional | 06/21/2002SE |
Questions and answers
When was Stanbio Alpha-Amylase Test Set, Catalog 0180-715 cleared by the FDA?
Stanbio Alpha-Amylase Test Set, Catalog 0180-715 (K870746) received a 510(k) decision of Substantially Equivalent on June 1, 1987, 96 days after the submission was received.
What is the product code of K870746?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.