Organon Teknika Corp. - FDA 510(k) Cleared Devices

Cleared Nov 14, 1995

AURAFLEX TESTOSTERONE CALIBRATOR PACK

K951685 · CDZ

Chemistry · 218d

Cleared May 08, 1995

AURAFLEX PROGESTERONE 150TEST PACK

K951630 · JLS

Chemistry · 31d

Cleared May 02, 1995

AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

K951638 · JHY

Chemistry · 22d

Cleared Apr 03, 1995

AURAFLEX(R) ESTRADIOL

K946199 · CHP

Chemistry · 104d

Cleared Mar 21, 1995

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1

K944698 · CFT

Chemistry · 179d

Cleared Mar 20, 1995

AURAFLEX HCG

K945331 · DHA

Chemistry · 139d

Cleared Mar 03, 1995

MICROPLATE PROCESSOR 3000

K945135 · JJE

Chemistry · 134d

Cleared Feb 22, 1995

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK

K944697 · CEC

Chemistry · 152d

Cleared Dec 09, 1994

IMX T3 ASSAY

K944808 · CDP

Chemistry · 71d

Cleared Aug 26, 1994

AURAFLEX SYSTEMS

K942443 · JJE

Chemistry · 95d

Cleared Jun 02, 1994

PREDICTOR HOME PREGNANCY TEST

K940637 · LCX

Chemistry · 108d

Cleared May 27, 1988

PREGNOSPIA II

K881435 · JHJ

Chemistry · 52d

Cleared Mar 15, 1988

HCG-NOSTICK

K880328 · JHJ

Chemistry · 49d

Cleared May 02, 1986

POSID SAMPLER

K860508 · JQW

Chemistry · 80d

Cleared Oct 25, 1985

NML TSH IRMA

K854087 · JLW

Chemistry · 18d

Cleared Aug 11, 1983

READER MICROELISA SYSTEM

K831641 · LIB

Chemistry · 80d

Cleared Aug 08, 1983

WASHER 6000 MICRO-C LISA SYSTEM

K831640 · JTC

Chemistry · 77d

Cleared Aug 01, 1983

PIPETTE 12 CHANNEL

K831644 · JTC

Chemistry · 70d

Cleared Jul 26, 1983

HEATING BLOCK MICROELISA SYSTEM

K831642 · LIB

Chemistry · 64d

Cleared Jul 26, 1983

STRIPREADER MICROELISA SYSTEM

K831643 · LIB

Chemistry · 64d

Cleared Jul 26, 1983

MICROELISA COMP

K831658 · LIB

Chemistry · 64d