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510(k) K963770

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS by Biocircuits Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1996
Date Received
September 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Biocircuits Corp.

  • K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS (October 13, 1998)
  • K980819 — BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (April 3, 1998)
  • K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (November 18, 1996)
  • K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (August 21, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (November 20, 1995)
  • K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE (November 20, 1995)

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