Atlas FDA

AMM

FDA 510(k) clearance K981467 · decided 1998-06-22

Clearance details

K-number
K981467
Device name
AMM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-04-23
Decision date
1998-06-22
Days to decision
60 days
Clearance type
Traditional
Product code
JIF
Device class
1
Regulation number
862.1065
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
Ammonia II (K183517)Roche Diagnostics Operations (Rdo)2019-02-08
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677)Siemens Healthcare Diagnostics2013-03-07
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320)Siemens Healthcare Diagnostics2013-02-15
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316)Dade Behring, Inc.2006-09-06
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114)Sentinel Ch. Srl2005-11-25
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921)Diagnostic Chemicals , Ltd.2004-03-10
RANDOX AMMONIA (K030873)Randox Laboratories, Ltd.2003-05-12
AMMONIA ASSAY FOR THE ADVIA 1650 (K023841)Bayer Diagnostics Corp.2002-12-24
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151)Bayer Diagnostics Corp.2002-07-13
SYNCHRON SYSTEMS AMMONIA REAGENT (K003196)Beckman Coulter, Inc.2000-12-22
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285)Diagnostic Chemicals , Ltd.2000-06-02
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402)Beckman Coulter, Inc.1999-01-29

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