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Orion Diagnostica, Inc.

28 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DIARLEX ROTA-ADENO (K942286)Orion Diagnostica, Inc.1994-12-14
SALIVA-STIM (K914892)Orion Diagnostica, Inc.1992-09-02
PYLORISET (K904655)Orion Diagnostica, Inc.1991-10-21
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (K884147)Orion Diagnostica, Inc.1988-10-27
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074)Orion Diagnostica, Inc.1988-10-27
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (K884040)Orion Diagnostica, Inc.1988-10-19
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (K884075)Orion Diagnostica, Inc.1988-10-19
ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)Orion Diagnostica, Inc.1987-06-04
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST (K871196)Orion Diagnostica, Inc.1987-05-06
RESPIRASTICK ENZYME IMMUNOASSAY TEST (K862475)Orion Diagnostica, Inc.1986-09-16
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS (K854129)Orion Diagnostica, Inc.1986-01-21
RESPIRALEX LATEX AGGLUTINATION TEST (K844399)Orion Diagnostica, Inc.1985-01-08
ROTALEX LATEX AGGLUTINATION TEST (K841319)Orion Diagnostica, Inc.1984-09-14
BIOCULT - GC CULTURE-PADDLES (K831124)Orion Diagnostica, Inc.1983-05-09
RESPIRACULT-STREP DEEP BED CULTURE PAD (K821659)Orion Diagnostica, Inc.1982-08-05
INFLUENZA A & B S-ANTIGEN & CONTROLS (K802931)Orion Diagnostica, Inc.1981-01-12
CYTOMEGALO VIRUS & CONTROLS (K802930)Orion Diagnostica, Inc.1981-01-09
MEASLES VIRUS & CONTROLS (K802932)Orion Diagnostica, Inc.1980-12-31
MUMPS S & V ANTIGENS & CONTROLS (K802933)Orion Diagnostica, Inc.1980-12-31
HERPES SIMPLEX TYPE I (K802939)Orion Diagnostica, Inc.1980-12-31
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & (K802936)Orion Diagnostica, Inc.1980-12-31
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (K802935)Orion Diagnostica, Inc.1980-12-31
RUBELLA VIRUS ANTIGENS & CONTROLS (K802937)Orion Diagnostica, Inc.1980-12-31
ADENO VIRUS & CONTROLS (K802929)Orion Diagnostica, Inc.1980-12-31
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (K802934)Orion Diagnostica, Inc.1980-12-31
VARICELLA-ZOSTER ANTIGENS & CONTROLS (K802938)Orion Diagnostica, Inc.1980-12-31
MYCOLOGY CULTURE SYSTEM (K802946)Orion Diagnostica, Inc.1980-12-22
ORICULT DTM (K802947)Orion Diagnostica, Inc.1980-12-22

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