Atlas FDA

AMY

FDA 510(k) clearance K981216 · decided 1998-06-08

Clearance details

K-number
K981216
Device name
AMY
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-04-03
Decision date
1998-06-08
Days to decision
66 days
Clearance type
Traditional
Product code
JFJ
Device class
2
Regulation number
862.1070
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, 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
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)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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30