Ortho Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K802404	ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE	DCF	1980-10-23	View
510(k)	K801507	ANTIGEN CONTROL CELLS	GOL	1980-08-20	View
510(k)	K800357	BI-LEVEL ASSAYED CARD. DRUG CONT., I,II	LAS	1980-04-16	View
510(k)	K800310	ORTHO ANTISERA CONTROL	KSF	1980-03-05	View
510(k)	K791791	ORTHO ANTIBODY ENHANCEMENT SOLUTION	KSG	1979-10-11	View
510(k)	K791301	ORTHO TSH RIA KIT	JLW	1979-09-24	View
510(k)	K790813	MULTECON BLOOD GAS CONTROL	JJS	1979-06-28	View
510(k)	K782166	SLIDE TEST FOR PREGNANCY, GRAVINDEX 90	JHJ	1979-04-04	View
510(k)	K782063	PREGNANCY, SENSIDEX TUBE TEST	JHJ	1979-04-04	View
510(k)	K781638	RUBINDEX*DIRECT SYSTEM	GOK	1978-12-20	View
510(k)	K781860	ASSAY, CHROMOGENIC ANTITHROMBIN III	JBQ	1978-12-04	View
510(k)	K781572	NORMAL HEMATOLOGY CONTROL UNASSAYED	JPK	1978-10-17	View
510(k)	K781573	ABNORMAL HEMATOLOGY CONTROL UNASSAYED	JPK	1978-10-17	View
510(k)	K781483	ORTHO*T-4 RIA (PEG) KIT	CDX	1978-09-27	View
510(k)	K781482	ORTHO*T-3 UPTAKE KIT	KHQ	1978-09-27	View
510(k)	K781481	ORTHO*T-3 RIA (PEG) KIT	CDP	1978-09-27	View
510(k)	K781435	ORTHO LOW IONIC SOLUTION	KSG	1978-09-14	View
510(k)	K781335	DIGOXIN RIA (PEG) KIT	DOG	1978-08-31	View
510(k)	K781104	PLASMA COAGULATION CONT., ABNORMAL	GFO	1978-08-10	View
510(k)	K780002	ANTITHROMBIN III ASSAY	JBQ	1978-01-31	View