JFJ — Catalytic Methods, Amylase Class II
FDA Device Classification
Classification Details
- Product Code
- JFJ
- Device Class
- Class II
- Regulation Number
- 862.1070
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K210633 | abbott ireland diagnostics division | Amylase2 | May 26, 2022 |
| K191454 | siemens healthcare diagnostics | Atellica CH Amylase_2 (AMY_2) | July 30, 2019 |
| K182474 | biosystems | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIR | May 2, 2019 |
| K130685 | hitachi chemical diagnostics | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | August 9, 2013 |
| K122858 | elitechgroup | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINIC | October 3, 2012 |
| K091846 | beckman coulter | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | October 16, 2009 |
| K080823 | medica | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | November 17, 2008 |
| K070064 | thermo fisher scientific | AMYLASE EPS REAGENT | May 22, 2007 |
| K062180 | horiba abx | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM | October 2, 2006 |
| K051447 | sentinel ch | SENTINEL PANCREATIC AMYLASE | January 26, 2006 |
| K040920 | teco diagnostics | AMYLASE LIQUID REAGENT, MODEL A532-200 | May 10, 2004 |
| K040534 | clinical data | VITALAB AMYLASE REAGENT | March 11, 2004 |
| K023549 | wiener laboratories saic | WIENER LAB AMILASA 405 AA LIQUIDA | December 9, 2002 |
| K020282 | jas diagnostics | JAS AMYLASE LIQUID REAGENT | February 28, 2002 |
| K013978 | beckman coulter | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | January 15, 2002 |
| K013101 | wiener laboratories saic | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIE | November 16, 2001 |
| K011843 | genzyme | GENZYME DIRECT-AMYLASE TEST REAGENT | August 10, 2001 |
| K011145 | roche diagnostics | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | June 25, 2001 |
| K001569 | sigma diagnostics | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | June 26, 2000 |
| K990025 | careside | CARESIDE AMYLASE | February 8, 1999 |