Medical Device Manufacturer · US , Irvine , CA

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

20 submissions · 20 cleared · Since 1988

20

Total

20

Cleared

0

Denied

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

12 devices

1-12 of 12

Cleared Sep 05, 1990

MODIFICATION OF SEROCARD RUBELLA IGG TEST

Microbiology · 90d

Cleared Aug 09, 1990

SEROCARD HSV IGG ANTIBODY TEST KIT

Microbiology · 28d

Cleared Nov 29, 1989

IMMUNOCARD STREP A TEST

Microbiology · 37d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD HERPES IGG TEST KIT

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD CMV IGG TEST KIT

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT

Microbiology · 181d

Cleared Mar 14, 1989

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

Microbiology · 169d

Cleared May 23, 1988

THE DDI SERODOT HERPES IGG TEST KIT

Microbiology · 144d

Cleared May 13, 1988

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT

Microbiology · 134d

Cleared Apr 21, 1988

SERODOT TOXOPLASMA IGG TEST KIT

Microbiology · 112d

Cleared Mar 23, 1988

THE DDI SERODOT RUBELLA IGG TEST KIT

Microbiology · 83d