FETALSCREEN

K Number: K820199 · Decision May 12, 1982

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

126

Review Days

106

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K Number	Device Name	Decision Date	Decision
K951459	ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE	Jul 14, 1997	Substantially Equivalent
K951632	ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)	Mar 6, 1997	Substantially Equivalent
K964754	ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE	Jan 22, 1997	Substantially Equivalent
K963902	QUANTITATIVE FIBRINOGEN ASSAY	Nov 29, 1996	Substantially Equivalent
K950625	ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent
K951100	ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent
K950568	ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent
K950482	ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)	May 10, 1996	Substantially Equivalent
K935720	ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM	May 9, 1996	Substantially Equivalent
K954570	ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM	Apr 30, 1996	Substantially Equivalent

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Applicant

Ortho Diagnostic Systems, Inc.

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