Atlas FDA

PHOS

FDA 510(k) clearance K981759 · decided 1998-06-16

Clearance details

K-number
K981759
Device name
PHOS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-05-19
Decision date
1998-06-16
Days to decision
28 days
Clearance type
Traditional
Product code
CEO
Device class
1
Regulation number
862.1580
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263)Seppim S.A.S.2011-05-06
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)Beckman Coulter, Inc.2004-08-18
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
PICCOLO PHOSPHORUS TEST SYSTEM (K022312)Abaxis, Inc.2002-09-05
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095)Wiener Laboratories Saic2001-11-16
PHOSPHORUS REAGENT (K003912)Jas Diagnostics, Inc.2001-02-21
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
HICHEM PHOSPHORUS REAGENT KIT (K981769)Elan Pharma, Inc.1998-06-29
CARESIDE ANALYZER (K981610)Careside, Inc.1998-06-25

Recalls involving this device

RecordFirmDate
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of recall (Z-0020-2014)Abbott Laboratories, Inc2013-10-17
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20 recall (Z-0722-2007)Abbott Laboratories Inc.2007-04-05

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