Medical Device Manufacturer · US , Washington , DC

Immunoprobe, Inc.

14 submissions · 14 cleared · Since 1994
14
Total
14
Cleared
0
Denied

Immunoprobe, Inc. — FDA 510(k) Submissions

Immunoprobe, Inc. has submitted 14 FDA 510(k) premarket notifications since 1994, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Anticardiolipin Immunological, Immunochemical, Thyroglobulin Autoantibody, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Test, Antigen, Nuclear, Epstein-barr Virus, Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · GOD Antigens, Cf (including... · Microbiology
Dec 1997 179d
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · LJZ Enzyme Linked... · Microbiology
Jul 1997 96d
PR-3 ELISA TEST SYSTEM
K961764 · MOB Test System,... · Immunology
Aug 1996 104d
MPO ELISA TEST SYSTEM
K961765 · MOB Test System,... · Immunology
Aug 1996 104d
EBNA IGG EIA TEST SYSTEM
K951549 · LLM Test, Antigen, Nuclear,... · Microbiology
Apr 1996 391d
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521 · MID System, Test,... · Immunology
Feb 1996 253d
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522 · MID System, Test,... · Immunology
Feb 1996 253d
CARDIOLIPIN IGG EIA TEST KIT
K952523 · MID System, Test,... · Immunology
Feb 1996 253d
THYROGLOBULIN EIA TEST KIT
K951362 · JNL Immunochemical,... · Immunology
Nov 1995 241d
MICROSOMAL EIA TEST KIT
K951364 · JNL Immunochemical,... · Immunology
Nov 1995 241d
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
K951363 · MID System, Test,... · Immunology
Oct 1995 203d
CARDIOLIPIN IGG,M,A EIA TEST KIT
K952520 · MID System, Test,... · Immunology
Sep 1995 106d
THYROGLOBULIN EIA TEST KIT
K941358 · JNL Immunochemical,... · Immunology
May 1994 51d
MICROSOMAL EIA TEST KIT
K941361 · JNL Immunochemical,... · Immunology
May 1994 51d
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