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510(k) K910833

COLOR VUE TM- MYCOPLASMA PNEUMONIAE by Seradyn, Inc. — Product Code GSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
February 27, 1991
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)
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  • K903958 — SEROFAST (December 21, 1990)
  • K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (October 25, 1988)
  • K862630 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (September 3, 1986)