Medical Device Manufacturer · US , Stillwater , MN

Incstar Corp. - FDA 510(k) Cleared Devices

58 submissions · 57 cleared · Since 1987

Recent clearances: INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY, INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565), INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)

58

Total

57

Cleared

0

Denied

FDA 510(k) Regulatory Record - Incstar Corp. Immunology ✕

29 devices

1-12 of 29

Cleared Oct 13, 1995

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)

Immunology · 186d

Cleared Jan 11, 1994

SPQ PAL CONTROL LEVEL II

Immunology · 88d

Cleared Jan 11, 1994

SPQ CRP CONTROL LEVEL II

Immunology · 78d

Cleared Jun 14, 1988

Immunology · 183d

Cleared May 11, 1988

MARSH ELDER ALLERGEN DISC

Immunology · 190d

Cleared May 11, 1988

WALNUT ALLERGEN DISC

Immunology · 162d

Cleared May 11, 1988

INCSTAR'S BIRCH ALLERGEN DISC

Immunology · 117d

Cleared May 11, 1988

INCSTAR'S PIGWEED ALLERGEN DISC

Immunology · 112d

Cleared Apr 21, 1988

GOLDENROD ALLERGEN DISC

Immunology · 127d

Cleared Apr 21, 1988

INCSTAR'S DANDELION ALLERGEN DISC

Immunology · 97d

Cleared Apr 21, 1988

MESQUITE ALLERGEN DISC

Immunology · 80d

Cleared Apr 21, 1988

WHITE ASH ALLERGEN DISC

Immunology · 71d