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510(k) K843138

CMV TEST by Microbiological Research Corp. — Product Code LIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1985
Date Received
August 9, 1984
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

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  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • 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)
  • K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (January 29, 1981)

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