510(k) K013101
- Device
- WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
- Applicant
- WIENER LABORATORIES S.A.I.C.
- 510(k) number
- K013101
- Product code
- JFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-16
- Date received
- 2001-09-17
- Regulation
- 862.1070
- Classification name
- Catalytic Methods, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIANA CETOLA
- Address
- 2944 Riobamba Rosario, Santa Fe AR 2000 2000
FDA Registration Numbers#
- 8040374
- 8020316
- 2030861
- 2517506
- 3016438761
- 3005333358
- 3006198300
- 3004493545
- 2085064
- 1616487
- 3002809144
- 3010825766
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 9610126
- 3003795116
- 1036362
- 1181121
- 1832216
- 3021841051
- 2050012
- 9610529
- 9681753
- 2050010
- 3007662974
- 1181055
- 2432235
Source Documents#
Other 510(k) Records For Product Code JFJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | 2022-05-26 |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | 2019-05-02 |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | 2012-10-03 |
| K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | Beckman Coulter, Inc. | 2009-10-16 |
| K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | 2008-11-17 |
| K070064 | AMYLASE EPS REAGENT | Thermo Fisher Scientific | 2007-05-22 |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Horiba Abx | 2006-10-02 |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | 2006-01-26 |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | 2004-05-10 |
| K040534 | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | 2004-03-11 |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2002-02-28 |
| K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | 2002-01-15 |
Legacy Summary#
summary
FDA Review#
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