Atlas FDA

Atellica CH Amylase_2 (AMY_2)

FDA 510(k) clearance K191454 · decided 2019-07-30

Clearance details

K-number
K191454
Device name
Atellica CH Amylase_2 (AMY_2)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2019-05-31
Decision date
2019-07-30
Days to decision
60 days
Clearance type
Traditional
Product code
JFJ
Device class
2
Regulation number
862.1070
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
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.

RecordFirmDate
Amylase2 (K210633)Abbott Ireland Diagnostics Division2022-05-26
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)Elitechgroup2012-10-03
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 Scientific2007-05-22
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP (K062180)Horiba Abx2006-10-02
SENTINEL PANCREATIC AMYLASE (K051447)Sentinel Ch. Srl2006-01-26
AMYLASE LIQUID REAGENT, MODEL A532-200 (K040920)Teco Diagnostics2004-05-10
VITALAB AMYLASE REAGENT (K040534)Clinical Data, Inc.2004-03-11
WIENER LAB AMILASA 405 AA LIQUIDA (K023549)Wiener Laboratories Saic2002-12-09

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16