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510(k) K930272

HEMAGEN CHAGAS' KIT (EIA METHOD) by Hemagen Diagnostics, Inc. — Product Code MIU

K930272 is an FDA 510(k) premarket notification submitted by Hemagen Diagnostics, Inc. for the device "HEMAGEN CHAGAS' KIT (EIA METHOD)". The FDA issued a decision of Substantially Equivalent on May 19, 1995. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Hemagen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1995
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

Other clearances by Hemagen Diagnostics, Inc.

  • K041052 — RAICHEM GLUCOSE UV (LIQUID) (June 30, 2004)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (June 16, 2003)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (September 17, 2002)
  • K022767 — RAICHEM LIPID CALIBRATOR (September 3, 2002)
  • K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (July 29, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012668 — RAICHEM GLUCOSE UV REAGENT (October 15, 2001)

Other clearances for product code MIU

  • K161947 — Chagas Detect Plus Rapid Test (December 16, 2016)
  • K072732 — ORTHO T. CRUZI ELISA TEST SYSTEM (April 15, 2009)
  • K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (February 11, 2004)
  • K933716 — ABBOTT CHAGAS ANTIBODY EIA (December 19, 1994)
  • K911233 — CHAGAS' IGG ELISA TEST (May 4, 1992)

FDA data resources