Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 11, 1992

ORTHO CHLAMYDIA ANTIGEN ELISA TEST

K921321 · LJC

Microbiology · 148d

Cleared Jun 22, 1992

MODIFIED ORTHO EBV VCA-IGG ELISA

K920412 · MCD

Microbiology · 143d

Cleared Apr 22, 1992

ORTHO HSV ANTIGEN ELISA TEST

K915551 · LGC

Microbiology · 133d

Cleared Jun 10, 1991

EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST

K911569 · LLM

Microbiology · 63d

Cleared Jun 10, 1991

EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST

K911570 · MCD

Microbiology · 63d

Cleared Jun 10, 1991

EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST

K911571 · MCD

Microbiology · 63d

Cleared May 20, 1991

ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY

K904253 · GKZ

Hematology · 248d

Cleared Mar 19, 1991

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION

K910668 · LJC

Microbiology · 34d

Cleared Dec 21, 1990

ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF

K903132 · LJC

Microbiology · 157d

Cleared Dec 17, 1990

ORTHO CMV-M ANTIBODY ELISA TEST

K905077 · LFZ

Microbiology · 34d

Cleared Dec 17, 1990

ORTHO CMV-G ANTIBODY ELISA TEST

K905078 · LFZ

Microbiology · 34d

Cleared Dec 04, 1990

ORTHO RUBELLA-M ANTIBODY ELISA TEST

K905079 · LFX

Microbiology · 21d

Cleared Jul 03, 1990

ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA

K902210 · GGN

Hematology · 48d

Cleared May 25, 1990

ORTHO CORRECTION REAGENTS

K901327 · GJT

Hematology · 65d

Cleared May 22, 1990

KOAGULAB 60-S COAGULATION SYSTEM

K901120 · GKP

Hematology · 71d

Cleared Apr 11, 1990

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA

K901233 · GGC

Hematology · 28d

Cleared Mar 15, 1990

ORTHOKROME* FACTOR VIII

K900395 · GGP

Hematology · 45d

Cleared Mar 15, 1990

ORTHOKROME* HEPARIN

K900396 · KFF

Hematology · 45d

Cleared Mar 15, 1990

ORTHOKROME* ANTIPLASMIN

K900397 · GGP

Hematology · 45d

Cleared Mar 15, 1990

ORTHOKROME* PROTEIN C

K900398 · GGP

Hematology · 45d

Cleared Mar 15, 1990

ORTHOKROME* PLASMINOGEN

K900399 · GGP

Hematology · 45d

Cleared Mar 15, 1990

ORTHOKROME* ANTITHROMBIN

K900400 · JBQ

Hematology · 45d

Cleared Dec 29, 1989

ORTHO* RUBELLA-G ANTIBODY ELISA TEST

K896479 · LFX

Microbiology · 46d

Cleared Oct 04, 1989

ORTHO RESULT PLUS/PREGNANCY

K894420 · JHI

Chemistry · 79d

Cleared Jun 06, 1989

ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES

K891382 · GQL

Microbiology · 89d