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510(k) K883083

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM by Medical Diagnostic Technologies, Inc. — Product Code GSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1988
Date Received
July 21, 1988
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

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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)
  • K903958 — SEROFAST (December 21, 1990)
  • K862630 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (September 3, 1986)