Medical Device Manufacturer · US , Mchenry , IL

Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices

164 submissions · 164 cleared · Since 1984
164
Total
164
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc. Immunology ✕
4 devices
1-4 of 4
Cleared Jan 20, 1995
IGM RF EIA
K942908 · DHR
Immunology · 213d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291 · LLL
Immunology · 147d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Immunology · 26d
Cleared Mar 28, 1986
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · DDB
Immunology · 73d
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All164 Chemistry 86 Hematology 42 Toxicology 16 Pathology 9 Microbiology 7 Immunology 4