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510(k) K770092

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

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

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Other clearances for product code GOL

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  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
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  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)