Atlas FDA

IMX B2-MICROGLOBULIN

FDA 510(k) clearance K890421 · decided 1989-03-09

Clearance details

K-number
K890421
Device name
IMX B2-MICROGLOBULIN
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1989-01-26
Decision date
1989-03-09
Days to decision
42 days
Clearance type
Traditional
Product code
JZG
Device class
2
Regulation number
866.5630
Medical specialty
Immunology
Advisory committee
Immunology
Location
Abbott Park, IL, 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
Beta-2-Microglobulin (K161297)Beckman Coulter Ireland, Inc.2016-06-07
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066)The Binding Site Group , Ltd.2012-08-30
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874)Siemens Healthcare Diagnostics, Inc.2012-01-20
HUMAN BETA-2 MICROGLOBULIN KIT (K083289)The Binding Site, Ltd.2009-05-06
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463)Siemens Healthcare Diagnostics2009-03-13
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078)Biokit, S.A.2007-12-19
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272)Dade Behring, Inc.2007-01-26
QUANTIA BETA-2 MICROGLOBULIN (K050613)Biokit, S.A.2005-08-16
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692)Dako A/S2004-01-22
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
N LATEX B2-MICROGLOBULIN (K002731)Dade Behring, Inc.2000-11-20
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (K001022)Biocheck, Inc.2000-09-26

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