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Orion Diagnostica, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstMarch 10, 2016
K043125ORION DIAGNOSTICA UNIQ PINP RIAMay 4, 2005
K042625QUIKREAD CRP CALIBRATOR SETNovember 18, 2004
K042442QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CSeptember 24, 2004
K942286DIARLEX ROTA-ADENODecember 14, 1994
K914892SALIVA-STIMSeptember 2, 1992
K904655PYLORISETOctober 21, 1991
K884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GOctober 27, 1988
K884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOctober 27, 1988
K884075IMMUNOCHEMICAL DETERMINATION OF TRANSFERRINOctober 19, 1988
K884040IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN AOctober 19, 1988
K864645ADENOLEX (R) LATEX AGGLUTINATION TESTJune 4, 1987
K871196RHEUMA-CHECK ENZYME IMMUNOASSAY TESTMay 6, 1987
K862475RESPIRASTICK ENZYME IMMUNOASSAY TESTSeptember 16, 1986
K854129ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUSJanuary 21, 1986
K844399RESPIRALEX LATEX AGGLUTINATION TESTJanuary 8, 1985
K841319ROTALEX LATEX AGGLUTINATION TESTSeptember 14, 1984
K831124BIOCULT - GC CULTURE-PADDLESMay 9, 1983
K821659RESPIRACULT-STREP DEEP BED CULTURE PADAugust 5, 1982
K802931INFLUENZA A & B S-ANTIGEN & CONTROLSJanuary 12, 1981