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510(k) K861123

THE GOLDEN QUAD TEST (CMV) by Microbiological Research Corp. — Product Code GQI

K861123 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "THE GOLDEN QUAD TEST (CMV)". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.

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
Antiserum, Cf, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Microbiological Research Corp.

  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (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)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

Other clearances for product code GQI

  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K942171 — CMV EARLY ANTIGEN TEST (June 30, 1994)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST (May 6, 1988)
  • K863488 — ENZYGNOST ANTI-CMV IGG TEST (July 20, 1987)
  • K864420 — CMV MICROASSAY (February 2, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K853989 — COR DOT CMV (June 13, 1986)
  • K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)

FDA data resources