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510(k) K912592

CMV-EA MAB TEST by Gull Laboratories, Inc. — Product Code LIN

K912592 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "CMV-EA MAB TEST". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
June 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
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 LIN

  • K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (June 13, 2008)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K991650 — CMV BRITE TURBO KIT (July 12, 1999)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K951550 — CMV BRITE ANTIGENEMIA TEST KIT (January 30, 1996)
  • K934798 — PATHODX CYTOMEGALOVIRUS (March 25, 1994)
  • K921616 — CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (August 11, 1992)
  • K905257 — OPUS CMV TEST SYSTEM (April 17, 1991)
  • K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (October 16, 1990)
  • K894002 — CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (August 10, 1989)

FDA data resources