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510(k) K852933

MYCOPLASMA SPP SEROLOGICAL REAGENTS by Microbix Biosystems, Inc. — Product Code GSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf, All, Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
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)
  • K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (November 12, 1985)

Other clearances for product code GSB

  • K843664 — MYCOPLASMA PNEUMONIAE (October 25, 1984)
  • K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGEN (February 27, 1984)
  • K832132 — SERA-TEK MYCOPLASMA ANTIBODY TEST (September 20, 1983)
  • K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (December 31, 1980)