Disease Detection International, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K943252	PRO-STEP LH OVULATION PREDICTION TEST	CEP	1994-10-25	View
510(k)	K925303	PRO-STEP PT HCG	JHI	1993-06-15	View
510(k)	K925125	PRO-STEP HCG	JHI	1993-01-13	View
510(k)	K911826	IMMUNOCARD HCG ONE STEP (I-S) TEST KIT	JHI	1991-07-19	View
510(k)	K902571	MODIFICATION OF SEROCARD RUBELLA IGG TEST	LFX	1990-09-05	View
510(k)	K903070	SEROCARD HSV IGG ANTIBODY TEST KIT	LGC	1990-08-09	View
510(k)	K895912	IMMUNOCARD HCG II-S TEST KIT	JHI	1989-12-01	View
510(k)	K896109	IMMUNOCARD STREP A TEST	GTZ	1989-11-29	View
510(k)	K884249	MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT	LGD	1989-04-10	View
510(k)	K884246	MODIFIED DDI SEROCARD HERPES IGG TEST KIT	LGC	1989-04-10	View
510(k)	K884247	MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT	LFX	1989-04-10	View
510(k)	K884248	MODIFIED DDI SEROCARD CMV IGG TEST KIT	LFZ	1989-04-10	View
510(k)	K884047	FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY	LYF	1989-03-14	View
510(k)	K883430	PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST	LCX	1989-01-30	View
510(k)	K881709	IMMUNOCARD(TM) HCG II TEST KIT	JHI	1988-07-08	View
510(k)	K875366	THE DDI SERODOT HERPES IGG TEST KIT	GQO	1988-05-23	View
510(k)	K875361	SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT	LFZ	1988-05-13	View
510(k)	K875363	SERODOT TOXOPLASMA IGG TEST KIT	LGD	1988-04-21	View
510(k)	K880410	HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT	JHI	1988-04-05	View
510(k)	K875368	THE DDI SERODOT RUBELLA IGG TEST KIT	LFX	1988-03-23	View