Atlas FDA

LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST

FDA 510(k) clearance K894279 · decided 1989-08-15

Clearance details

K-number
K894279
Device name
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1989-06-23
Decision date
1989-08-15
Days to decision
53 days
Clearance type
Traditional
Product code
CEP
Device class
1
Regulation number
862.1485
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lakes, NJ, 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
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05