Medical Device Manufacturer · US , Stillwater , MN

Incstar Corp.

58 submissions · 57 cleared · Since 1987
58
Total
57
Cleared
0
Denied

Incstar Corp. — FDA 510(k) Submissions

Incstar Corp. has submitted 58 FDA 510(k) premarket notifications since 1987, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological, Radioimmunoassay, Parathyroid Hormone, Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, Epstein-barr Virus, Other, Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii . Use the specialty filter in the sidebar to narrow results.

58 devices
1–12 of 58
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
K963289 · LGD Enzyme Linked... · Microbiology
May 1997 253d
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · LGD Enzyme Linked... · Microbiology
Dec 1996 117d
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · LGD Enzyme Linked... · Microbiology
Dec 1996 117d
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · LFX Enzyme Linked... · Microbiology
Oct 1996 273d
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · LFX Enzyme Linked... · Microbiology
Oct 1996 273d
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · LFZ Enzyme Linked... · Microbiology
Oct 1996 260d
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · MRG System, Test, Vitamin D · Chemistry
Sep 1996 422d
INCSTAR HSV I/II IGG FAST ELISA ASSAY
K955362 · IGC Formalin-saline · Microbiology
Jul 1996 245d
INCSTAR HSZ I/II IGG ELISA ASSAY
K955363 · IGC Formalin-saline · Microbiology
Jul 1996 245d
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · LFZ Enzyme Linked... · Microbiology
Jul 1996 243d
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · LFZ Enzyme Linked... · Microbiology
Jul 1996 243d
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639 · DAE Complement C9, Antigen,... · Immunology
Oct 1995 186d

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