Home / 510(k) Clearances / K911233

510(k) K911233

CHAGAS' IGG ELISA TEST by Gull Laboratories, Inc. — Product Code MIU

K911233 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "CHAGAS' IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on May 4, 1992. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1992
Date Received
March 20, 1991
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 Gull Laboratories, Inc.

  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K941624 — RUBELLA IGG ELISA TEST (August 4, 1995)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

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)
  • K930272 — HEMAGEN CHAGAS' KIT (EIA METHOD) (May 19, 1995)
  • K933716 — ABBOTT CHAGAS ANTIBODY EIA (December 19, 1994)

FDA data resources