Atlas FDA

A-GENT ALBUMIN

FDA 510(k) clearance K770822 · decided 1977-07-11

Clearance details

K-number
K770822
Device name
A-GENT ALBUMIN
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1977-05-04
Decision date
1977-07-11
Days to decision
68 days
Clearance type
Traditional
Product code
CIX
Device class
2
Regulation number
862.1035
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, 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
Core Metabolic (K251157)Truvian Health2026-01-09
Albumin BCG2 (K203248)Abbott Ireland Diagnostics Division2021-11-23
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (K200898)Medicon Hellas S.A2021-09-21
VITROS XT Chemistry Products ALB-TP Slides (K191316)Ortho-Clinical Diagnostics, Inc.2019-06-07
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (K170901)Biosystems S.A.2018-04-13
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT (K131488)Alfa Wassermann Diagnostics Technologies, LLC2013-08-19
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT (K113374)Alfa Wassermann Diagnostic Technologies, Inc.2012-07-13
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS (K110818)Polymedco, Inc.2011-09-08
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH (K110830)Elitechgroup2011-06-21
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (K101088)Medica Corp.2011-04-04
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT (K080874)Medica Corp.2009-02-20
S40 CLINICAL ANALYZER, S TEST ALB (K072143)Alfa Wassermann Diagnostic Technologies, Inc.2008-07-14

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