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510(k) K894262

RUBELLA ANTIGEN AND CONTROL ANTIGEN by Microbix Biosystems, Inc. — Product Code GON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
June 21, 1989
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

Other clearances by Microbix Biosystems, Inc.

  • K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K852931 — HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (November 12, 1985)
  • K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (November 12, 1985)
  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)

Other clearances for product code GON

  • K880157 — MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (February 4, 1988)
  • K802937 — RUBELLA VIRUS ANTIGENS & CONTROLS (December 31, 1980)
  • K802939 — HERPES SIMPLEX TYPE I (December 31, 1980)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)