JFJ — Catalytic Methods, Amylase Class II
FDA product code JFJ covers "Catalytic Methods, Amylase", a Class II medical device regulated under 21 CFR 862.1070. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |