Atlas FDA

ABBOTT IMX LH

FDA 510(k) clearance K884138 · decided 1988-11-29

Clearance details

K-number
K884138
Device name
ABBOTT IMX LH
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1988-09-30
Decision date
1988-11-29
Days to decision
60 days
Clearance type
Traditional
Product code
CEP
Device class
1
Regulation number
862.1485
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
MAYBE?MOM MINI OVULATION MICROSCOPE (K013582)Maybe?Mom2003-01-16
INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829)Alfa Scientific Designs, Inc.2002-11-05
AT HOME OVULATION TEST, MODEL 9032 (K021409)Phamatech, Inc.2002-05-24
CLEARPLANE EASY OVULATION TEST (K013874)Unipath , Ltd.2002-02-19
TCI-31 LIFELONG OVULATION TESTER (K013323)Tci New York2001-12-05
QUIK-CHECK OVULATION PREDICTOR (K012252)ACON Laboratories, Inc.2001-08-24
SURE CHECK OVULATION PREDICTOR (K010244)Chembio Diagnostic Systems, Inc.2001-05-02
INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867)Selfcare, Inc.2000-10-12
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466)Selfcare, Inc.1999-05-25
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386)Selfcare, Inc.1999-05-25
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249)Phamatech1999-03-22
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113)Syntron Bioresearch, Inc.1998-11-18

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