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510(k) K802937

RUBELLA VIRUS ANTIGENS & CONTROLS by Orion Diagnostica, Inc. — Product Code GON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code GON

  • K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K880157 — MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (February 4, 1988)
  • K802939 — HERPES SIMPLEX TYPE I (December 31, 1980)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)