FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Cleared Jan 26, 1998

BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST

K974821

Quidel Corp.

Chemistry · 34d

Cleared Dec 19, 1997

SIGNAL PREGNANCY TEST KIT

K974021

Sa Scientific, Inc.

Chemistry · 58d

Cleared Dec 19, 1997

CHOICE ACCU-TEST PREGNANCY TEST KIT

K974154

Sa Scientific, Inc.

Chemistry · 45d

Cleared Oct 31, 1997

QUICK CARD HCG ONE STEP PREGNANCY TEST

K973570

Phamatech

Chemistry · 42d

Cleared Oct 27, 1997

BRAND NAME *1-STEP PREGNANCY

K973352

Armkel, LLC

Chemistry · 52d

Cleared Aug 01, 1997

QUICKSTICK ONE STEP HCG PREGNANCY TEST

K972682

Phamatech

Chemistry · 15d

Cleared Jan 24, 1997

ABBOTT ADVISOR ONE-STEP PREGNANCY TEST

K970082

Abbott Laboratories

Chemistry · 15d

Cleared Jul 23, 1996

QUICKSTICK ONE STEP PREGNANCY TEST(9010)

K962219

Phamatech

Chemistry · 43d

Cleared Jul 10, 1996

BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES

K962183

Armkel, LLC

Chemistry · 34d

Cleared May 31, 1996

TBD AT-HOME PREGNANCY TEST

K961712

Armkel, LLC

Chemistry · 29d

Cleared Apr 29, 1996

CLEARBLUE EASY

K960316

Unipath , Ltd.

Chemistry · 97d

Cleared Oct 13, 1995

CAMEO HOME PREGNANCY TEST

K954364

Quidel Corp.

Chemistry · 25d

Cleared Feb 10, 1995

LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG

K945514

Princeton BioMeditech Corp.

Chemistry · 93d

Cleared Jul 06, 1994

PREGNANCY CHECK

K941355

Sa Scientific, Inc.

Chemistry · 107d

Cleared Jun 02, 1994

PREDICTOR HOME PREGNANCY TEST

K940637

Organon Teknika Corp.

Chemistry · 108d

Cleared Mar 18, 1993

PRECISE PREGNANCY

K930640

Bd Becton Dickinson Vacutainer Systems Preanalytic

Chemistry · 49d

Cleared Dec 28, 1992

CONCEIVE ONE-STEP PREGNANCY TEST

K925096

Quidel Corp.

Chemistry · 81d

Cleared Apr 08, 1992

PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG

K921012

Bd Becton Dickinson Vacutainer Systems Preanalytic

Chemistry · 36d

Cleared Oct 17, 1991

FIRST RESPONSE(R) ONE-STEP

K914304

Armkel, LLC

Chemistry · 22d

Cleared May 06, 1991

CLEARBLUE EASY

K911566

Unipath , Ltd.

Chemistry · 27d

Cleared Feb 13, 1991

CLEARBLUE EASY

K905742

Unipath , Ltd.

Chemistry · 51d

Cleared Aug 02, 1990

ABBOTT MODIFIED FACT PLUS PREGNANCY TEST

K901981

Abbott Laboratories

Chemistry · 92d

Cleared Jul 28, 1988

CLEARBLUE EASY

K882416

Unipath , Ltd.

Chemistry · 45d

Cleared Apr 05, 1988

FIRST RESPONSE 5 MINUTE PREGNANCY TEST

K874823

Tambrands, Inc.

Chemistry · 133d