Medical Device Manufacturer · US , Mchenry , IL

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

24 submissions · 24 cleared · Since 1977

Total

Cleared

Denied

Ortho Diagnostics, Inc. has 24 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 24 cleared submissions from 1977 to 1980. Primary specialty: Hematology.

Browse the FDA 510(k) cleared devices submitted by Ortho Diagnostics, Inc. Filter by specialty or product code using the sidebar.

Ortho Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Ortho Diagnostics, Inc.

24 devices

1-24 of 24

Cleared Oct 23, 1980

ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE

K802404 · DCF

Immunology · 17d

Cleared Aug 20, 1980

ANTIGEN CONTROL CELLS

K801507 · GOL

Microbiology · 51d

Cleared Apr 16, 1980

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II

K800357 · LAS

Toxicology · 56d

Cleared Mar 05, 1980

ORTHO ANTISERA CONTROL

K800310 · KSF

Hematology · 22d

Cleared Oct 11, 1979

ORTHO ANTIBODY ENHANCEMENT SOLUTION

MULTECON BLOOD GAS CONTROL

K790813 · JJS

Chemistry · 62d

Cleared Apr 04, 1979

PREGNANCY, SENSIDEX TUBE TEST

K782063 · JHJ

Chemistry · 114d

Cleared Apr 04, 1979

SLIDE TEST FOR PREGNANCY, GRAVINDEX 90

K782166 · JHJ

Chemistry · 96d

Cleared Dec 20, 1978

RUBINDEX*DIRECT SYSTEM

K781638 · GOK

Immunology · 90d

Cleared Dec 04, 1978

ASSAY, CHROMOGENIC ANTITHROMBIN III

K781860 · JBQ

Chemistry · 28d

Cleared Oct 17, 1978

NORMAL HEMATOLOGY CONTROL UNASSAYED

K781572 · JPK

Hematology · 33d

Cleared Oct 17, 1978

ABNORMAL HEMATOLOGY CONTROL UNASSAYED

K781573 · JPK

Hematology · 33d

Cleared Sep 27, 1978

ORTHO*T-3 RIA (PEG) KIT

ORTHO*T-4 RIA (PEG) KIT

K781483 · CDX

Chemistry · 30d

Cleared Sep 14, 1978

ORTHO LOW IONIC SOLUTION

K781435 · KSG

Hematology · 29d

Cleared Aug 31, 1978

DIGOXIN RIA (PEG) KIT

K781335 · DOG

Immunology · 29d

Cleared Aug 10, 1978

PLASMA COAGULATION CONT., ABNORMAL

K781104 · GFO

Hematology · 38d

Cleared Jan 31, 1978

ANTITHROMBIN III ASSAY

K780002 · JBQ

Hematology · 32d

Cleared Nov 08, 1977

LEWIS BLOOD GROUP SUBSTANCE

K771487 · KSX

Hematology · 95d

Cleared Nov 08, 1977

P1 BLOOD GROUP SUBSTANCE

K771488 · KSX

Hematology · 95d

Cleared Nov 07, 1977

REAGENT CONFIDENCE SERA

K771814 · KSF

Hematology · 41d

Cleared Feb 07, 1977

MICROSAMPLE BLOOD COLLECTION DEVICE

K761137 · GKH

Hematology · 75d

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

FDA 510(k) Regulatory Record - Ortho Diagnostics, Inc.

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