Medical Device Manufacturer · US , Irvine , CA

Disease Detection International, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1988

Recent clearances: PRO-STEP LH OVULATION PREDICTION TEST, PRO-STEP PT HCG, PRO-STEP HCG

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Disease Detection International, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Oct 25, 1994

PRO-STEP LH OVULATION PREDICTION TEST

Chemistry · 111d

Cleared Jun 15, 1993

PRO-STEP PT HCG

Chemistry · 237d

Cleared Jan 13, 1993

Chemistry · 92d

Cleared Jul 19, 1991

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT

Chemistry · 86d

Cleared Dec 01, 1989

IMMUNOCARD HCG II-S TEST KIT

Chemistry · 52d

Cleared Jan 30, 1989

PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST

Chemistry · 168d

Cleared Jul 08, 1988

IMMUNOCARD(TM) HCG II TEST KIT

Chemistry · 79d

Cleared Apr 05, 1988

HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT

Chemistry · 64d