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510(k) K903958

SEROFAST by Intl. Mycoplasma/Mdc Assoc. — Product Code GSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1990
Date Received
August 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
Review Panel
MI
Submission Type

Other clearances for product code GSA

  • K950073 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (October 17, 1995)
  • K910833 — COLOR VUE TM- MYCOPLASMA PNEUMONIAE (June 24, 1991)
  • K905493 — MERISTAR-MP (January 30, 1991)
  • K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (October 25, 1988)
  • K862630 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (September 3, 1986)