Medical Device Manufacturer · US , Mchenry , IL

Litton Bionetics

15 submissions · 15 cleared · Since 1978
15
Total
15
Cleared
0
Denied

Litton Bionetics — FDA 510(k) Submissions

Litton Bionetics has submitted 15 FDA 510(k) premarket notifications since 1978, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antigens, If, Toxoplasma Gondii, Antiserum, Fluorescent, Epstein-barr Virus, Antigen, Ha (including Ha Control), Rubella, Antigen, Cf (including Cf Control), Cytomegalovirus, Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
EBNA ACIF KIT
K840417 · LLM Test, Antigen, Nuclear,... · Microbiology
Dec 1984 331d
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
K834443 · LIQ Enzyme Linked... · Immunology
Mar 1984 91d
CMV RQ BIO-ENZABEAD KIT
K831343 · LFZ Enzyme Linked... · Immunology
Aug 1983 105d
EBV-M KIT
K822985 · JRY Antiserum, Fluorescent,... · Microbiology
Dec 1982 52d
RUBELLA RQ BIO-ENZABEAD KIT
K821804 · LFX Enzyme Linked... · Microbiology
Sep 1982 89d
TOXO BIO-BEAD TITRATION KIT
K801720 · GLZ Antigens, If, Toxoplasma... · Microbiology
Sep 1980 55d
HSV BIO-BEAD TITRATION KIT
K801721 · GQN Antigen, Cf (including Cf... · Microbiology
Sep 1980 55d
CMV BIO-BEAD TITRATION KIT
K801722 · GQH Antigen, Cf (including Cf... · Microbiology
Sep 1980 55d
RUBELLA BIO-BEAD TITRATION KIT
K800789 · GOL Antigen, Ha (including Ha... · Microbiology
Jun 1980 83d
RUBELLA BIO-BEAD SCREEN KIT
K791610 · GOL Antigen, Ha (including Ha... · Microbiology
Nov 1979 84d
TOXO BIO-BEAD SCREEN KIT
K791611 · GLZ Antigens, If, Toxoplasma... · Microbiology
Nov 1979 84d
CMV BIO-BEAD SCREEN KIT
K791612 · GQH Antigen, Cf (including Cf... · Microbiology
Nov 1979 84d
HSV BIO-BEAD SCREEN KIT
K791614 · GQN Antigen, Cf (including Cf... · Microbiology
Nov 1979 84d
TORCH BIO-BEAD SCREEN KIT
K791618 · GLZ Antigens, If, Toxoplasma... · Microbiology
Nov 1979 85d
EB-VCA, TEST, ANTIBODY, FLUORESCENT
K780925 · JRY Antiserum, Fluorescent,... · Microbiology
Jun 1978 16d
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