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510(k) K910872

EBV IGG ELISA TEST by Gull Laboratories, Inc. — Product Code MCD

K910872 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "EBV IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
March 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ebv, Capsid
Device Class
Class I
Regulation Number
866.3235
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)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)

Other clearances for product code MCD

  • K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYM (January 11, 1999)
  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)
  • K924091 — EBV-VCA IGG ELISA TEST SYSTEM (January 11, 1993)
  • K920412 — MODIFIED ORTHO EBV VCA-IGG ELISA (June 22, 1992)
  • K911570 — EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (June 10, 1991)
  • K911571 — EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (June 10, 1991)

FDA data resources