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510(k) K852932

MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT by Microbix Biosystems, Inc. — Product Code GRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Rubeola
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

Other clearances by Microbix Biosystems, Inc.

  • K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • 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)
  • K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (November 12, 1985)
  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)

Other clearances for product code GRF

  • K922870 — THREE SPIKE CUP (April 8, 1993)