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510(k) K862630

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1986
Date Received
July 10, 1986
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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  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
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  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)

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)
  • K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (October 25, 1988)