Medical Device Manufacturer · US , Mchenry , IL

Antibodies, Inc.

16 submissions · 16 cleared · Since 1977
16
Total
16
Cleared
0
Denied

Antibodies, Inc. — FDA 510(k) Submissions

Antibodies, Inc. has submitted 16 FDA 510(k) premarket notifications since 1977, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Nephelometric, Immunoglobulins (g, A, M), Radioimmunoassay, Thyroid-stimulating Hormone, Radioimmunoassay, Tobramycin, Radioimmunoassay, Amikacin, Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
GIARDEIA(TM)
K890774 · KHW Antigen, Id, Ha, Cep,... · Microbiology
Apr 1989 48d
DETECT-A-STREP
K843590 · GTZ Antisera, All Groups,... · Microbiology
Oct 1984 48d
CORTISOL RIA KIT
K822892 · CGR Radioimmunoassay, Cortisol · Chemistry
Nov 1982 34d
ULTRA-DIG
K812749 · LCS Radioimmunoassay, Digoxin... · Toxicology
Oct 1981 20d
CRITHIDNA ANTI-DNA TEST KIT
K812314 · DHN Antinuclear Antibody,... · Immunology
Sep 1981 15d
AMIKACIN RIA KIT
K802877 · KLQ Radioimmunoassay, Amikacin · Chemistry
Dec 1980 32d
TOBRAMYCIN RIA KIT
K800743 · KLB Radioimmunoassay, Tobramycin · Toxicology
Apr 1980 13d
TSH RIA KIT
K791217 · JLW Radioimmunoassay,... · Chemistry
Sep 1979 64d
NEPHELRATE ANTISERUMS C3C
K781653 · CZW Complement C3, Antigen,... · Immunology
Nov 1978 42d
NEPHELRATE ANTIPERUMS LGM
K781654 · CFN Method, Nephelometric,... · Immunology
Nov 1978 42d
NEPHELRATE ANTISERUMS 1GA
K781655 · CFN Method, Nephelometric,... · Immunology
Nov 1978 42d
NEPHELRATE ANTISERUMS, IGG
K781656 · CFN Method, Nephelometric,... · Immunology
Nov 1978 42d
GENTAMICIN RIA KIT
K780516 · DJB Radioimmunoassay,... · Immunology
Apr 1978 29d
T3 RIA KIT
K772122 · CDP Radioimmunoassay, Total... · Immunology
Nov 1977 7d
DIGOXIN RIA KIT
K771877 · DNJ Radioimmunoassay, Digoxin... · Immunology
Oct 1977 17d
T3 UPTAKE DIAG. KIT
K771585 · Chemistry
Sep 1977 26d
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