Atlas FDA

ABBOTT IMX PROLACTIN

FDA 510(k) clearance K896162 · decided 1990-01-19

Clearance details

K-number
K896162
Device name
ABBOTT IMX PROLACTIN
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1989-10-24
Decision date
1990-01-19
Days to decision
87 days
Clearance type
Traditional
Product code
CFT
Device class
1
Regulation number
862.1625
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921)Monobind1997-06-24
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
DSL ACTIVE PROLACTIN IRMA (K960060)Diagnostic Systems Laboratories, Inc.1996-02-29
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21

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