SENTINEL PANCREATIC AMYLASE
FDA 510(k) clearance K051447 · decided 2006-01-26
Clearance details
- K-number
- K051447
- Device name
- SENTINEL PANCREATIC AMYLASE
- Applicant
- Sentinel Ch. Srl
- Decision
- Substantially Equivalent
- Date received
- 2005-06-02
- Decision date
- 2006-01-26
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- JFJ
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milano, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Amylase2 (K210633) | Abbott Ireland Diagnostics Division | 2022-05-26 |
| Atellica CH Amylase_2 (AMY_2) (K191454) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 |
| alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474) | Biosystems S.A. | 2019-05-02 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685) | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 |
| ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II (K122858) | Elitechgroup | 2012-10-03 |
| SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (K091846) | Beckman Coulter, Inc. | 2009-10-16 |
| EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (K080823) | Medica Corp. | 2008-11-17 |
| AMYLASE EPS REAGENT (K070064) | Thermo Fisher Scientific | 2007-05-22 |
| ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP (K062180) | Horiba Abx | 2006-10-02 |
| AMYLASE LIQUID REAGENT, MODEL A532-200 (K040920) | Teco Diagnostics | 2004-05-10 |
| VITALAB AMYLASE REAGENT (K040534) | Clinical Data, Inc. | 2004-03-11 |
| WIENER LAB AMILASA 405 AA LIQUIDA (K023549) | Wiener Laboratories Saic | 2002-12-09 |
Recalls involving this device
No recalls on record reference this clearance.