Medical Device Manufacturer · US , Irvine , CA

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

20 submissions · 20 cleared · Since 1988

Total

Cleared

Denied

Disease Detection International, Inc. has 20 FDA 510(k) cleared medical devices. Based in Irvine, US.

Historical record: 20 cleared submissions from 1988 to 1994. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Disease Detection International, Inc. Filter by specialty or product code using the sidebar.

Disease Detection International, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

20 devices

1-20 of 20

Cleared Oct 25, 1994

PRO-STEP LH OVULATION PREDICTION TEST

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT

K911826 · JHI

Chemistry · 86d

Cleared Sep 05, 1990

MODIFICATION OF SEROCARD RUBELLA IGG TEST

K902571 · LFX

Microbiology · 90d

Cleared Aug 09, 1990

SEROCARD HSV IGG ANTIBODY TEST KIT

K903070 · LGC

Microbiology · 28d

Cleared Dec 01, 1989

IMMUNOCARD HCG II-S TEST KIT

K895912 · JHI

Chemistry · 52d

Cleared Nov 29, 1989

IMMUNOCARD STREP A TEST

K896109 · GTZ

Microbiology · 37d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD HERPES IGG TEST KIT

K884246 · LGC

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT

K884247 · LFX

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD CMV IGG TEST KIT

K884248 · LFZ

Microbiology · 181d

Cleared Apr 10, 1989

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT

K884249 · LGD

Microbiology · 181d

Cleared Mar 14, 1989

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

K884047 · LYF

Microbiology · 169d

Cleared Jan 30, 1989

PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST

K883430 · LCX

Chemistry · 168d

Cleared Jul 08, 1988

IMMUNOCARD(TM) HCG II TEST KIT

K881709 · JHI

Chemistry · 79d

Cleared May 23, 1988

THE DDI SERODOT HERPES IGG TEST KIT

K875366 · GQO

Microbiology · 144d

Cleared May 13, 1988

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT

K875361 · LFZ

Microbiology · 134d

Cleared Apr 21, 1988

SERODOT TOXOPLASMA IGG TEST KIT

K875363 · LGD

Microbiology · 112d

Cleared Apr 05, 1988

HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT

K880410 · JHI

Chemistry · 64d

Cleared Mar 23, 1988

THE DDI SERODOT RUBELLA IGG TEST KIT

K875368 · LFX

Microbiology · 83d

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

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

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