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510(k) K861120

THE GOLDEN QUAD TEST (HSV) by Microbiological Research Corp. — Product Code GQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
March 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Microbiological Research Corp.

  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821018 — ANTIHUMAN IGG GLOBULIN FITC LABELED (April 29, 1982)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (January 29, 1981)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

Other clearances for product code GQO

  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)
  • K875366 — THE DDI SERODOT HERPES IGG TEST KIT (May 23, 1988)
  • K871426 — VIROGEN HSV ANTIBODY TEST (October 15, 1987)
  • K854712 — VISIBLE-HERPES TM TEST SYSTEM (May 20, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)