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510(k) K770092

HERPESIVIRUS TEST (TYPE L & 2) by Microbiological Research Corp. — Product Code GOL

K770092 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "HERPESIVIRUS TEST (TYPE L & 2)". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code GOL (Antigen, Ha (Including Ha Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
January 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
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)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (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)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K834032 — RUBAQUICK DIAGNOSTIC KIT (April 17, 1984)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)

FDA data resources