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510(k) K861716

FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY by Whittaker Bioproducts, Inc. — Product Code GRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)

Other clearances for product code GRZ

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  • K944417 — ZEUA MYCOPLASMA (August 1, 1995)
  • K931557 — FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (March 11, 1994)
  • K840012 — INDIRECT FLUORESCENT ANTIBODY MYCO (February 27, 1984)