Armkel, LLC - FDA 510(k) Cleared Devices

Cleared Oct 19, 2004

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

K040866 · LCX

Chemistry · 200d

Cleared Feb 25, 2003

FIRST RESPONSE PREGNANCY TEST

K030258 · LCX

Chemistry · 32d

Cleared Dec 21, 1999

FIRST RESPONSE 1-STEP PREGNANCY

K992232 · LCX

Chemistry · 172d

Cleared Oct 27, 1997

TBD* ONE-STEP OVULATION PREDICTOR TEST

K973310 · CEP

Chemistry · 54d

Cleared Oct 27, 1997

BRAND NAME *1-STEP PREGNANCY

K973352 · LCX

Chemistry · 52d

Cleared Jul 10, 1996

BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE,...

K962183 · LCX

Chemistry · 34d

Cleared May 31, 1996

TBD AT-HOME PREGNANCY TEST

K961712 · LCX

Chemistry · 29d

Cleared Oct 03, 1995

FIRST RESPONSE OVULATION PREDICTOR TEST

K953581 · CEP

Chemistry · 63d

Cleared Oct 17, 1991

FIRST RESPONSE(R) ONE-STEP

K914304 · LCX

Chemistry · 22d

Cleared Feb 26, 1990

POSITIVE AND NEGATIVE HCG SERUM CONTROLS

K896875 · JJX

Chemistry · 80d

Cleared Aug 31, 1989

POSITIVE AND NEGATIVE HCG URINE CONTROLS

K894181 · JJX

Chemistry · 76d

Cleared Oct 02, 1987

ANSWER OVULATION TEST KIT

K871241 · CEP

Chemistry · 189d