Atlas FDA

ABBOTT IMX IGE

FDA 510(k) clearance K895914 · decided 1989-11-13

Clearance details

K-number
K895914
Device name
ABBOTT IMX IGE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1989-10-10
Decision date
1989-11-13
Days to decision
34 days
Clearance type
Traditional
Product code
DGC
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
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
Kenota 1 Total IgE; Kenota 1 (instrument) (K231151)Kenota, Inc.2024-05-31
Quantia IgE (K214068)Biokit, S.A.2023-02-21
Total Immunoglobulin E (IgE) (K220178)Beckman Coulter, Inc.2022-03-23
ADVIA Centaur Total IgE (tIgE) (K193493)Siemens Healthcare Diagnostics, Inc.2020-01-15
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (K161899)Phadia AB2016-07-28
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404)Phadia AB2014-02-24
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH (K063425)Dade Behring, Inc.2007-02-15
QUANTIA IGE (K050493)Biokit, S.A.2005-08-16
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241)Kamiya Biomedical Co.2004-12-10
LACRYTEST (K034057)Adiatec SA2004-03-09
IMMUNETECH TOTAL IGE SYSTEM (K032251)Immunetech Corporation2003-12-19
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210)Beckman Coulter, Inc.2003-02-24

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