Medical Device Manufacturer · US , Sunnyvale , CA

Biocircuits Corp.

8 submissions · 8 cleared · Since 1995
8
Total
8
Cleared
0
Denied

Biocircuits Corp. — FDA 510(k) Submissions

Biocircuits Corp. has submitted 8 FDA 510(k) premarket notifications since 1995, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine, System, Test, Human Chorionic Gonadotropin, Multi-analyte Controls, All Kinds (assayed), Radioimmunoassay, Free Thyroxine, Prostate-specific Antigen (psa) For Management Of Prostate Cancers . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
K981634 · LTJ Prostate-specific Antigen... · Immunology
Oct 1998 158d
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
K980819 · CEC Radioimmunoassay, Free... · Chemistry
Apr 1998 31d
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
K963770 · JJY Multi-analyte Controls,... · Chemistry
Dec 1996 77d
BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
K961566 · JLW Radioimmunoassay,... · Chemistry
Nov 1996 209d
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
K961792 · DHA System, Test, Human... · Chemistry
Aug 1996 104d
BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
K952719 · KHO Fluorometer, For Clinical... · Chemistry
Nov 1995 160d
BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
K952751 · KLI Enzyme Immunoassay,... · Chemistry
Nov 1995 158d
BIOCIRCUITS IOS T4 TEST CARTRIDGE
K953837 · KLI Enzyme Immunoassay,... · Chemistry
Nov 1995 97d
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