Medical Device Manufacturer · US , Mchenry , IL

Orion Diagnostica, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1980

Total

Cleared

Denied

Orion Diagnostica, Inc. has 28 FDA 510(k) cleared microbiology devices. Based in Mchenry, US.

Historical record: 28 cleared submissions from 1980 to 1994.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Orion Diagnostica, 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 - Orion Diagnostica, Inc.

28 devices

1-12 of 28

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G

K884074 · DAH

Immunology · 30d

Cleared Oct 27, 1988

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M

K884147 · DFT

Chemistry · 24d

Cleared Oct 19, 1988

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

K884040 · CZP

Immunology · 23d

Cleared Oct 19, 1988

IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN

K884075 · DDG

Immunology · 22d

Cleared Jun 04, 1987

ADENOLEX (R) LATEX AGGLUTINATION TEST

K864645 · GOD

Microbiology · 191d

Cleared May 06, 1987

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST

K871196 · DHR

Immunology · 43d

Cleared Sep 16, 1986

RESPIRASTICK ENZYME IMMUNOASSAY TEST

K862475 · GTY

Microbiology · 78d

Cleared Jan 21, 1986

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

K854129 · LIQ

Microbiology · 104d

Cleared Jan 08, 1985

RESPIRALEX LATEX AGGLUTINATION TEST

K844399 · GTZ

Immunology · 56d

Orion Diagnostica, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Orion Diagnostica, Inc.

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