Home / 510(k) Clearances / K861716

510(k) K861716

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

K861716 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY". The FDA issued a decision of Substantially Equivalent on August 8, 1986. The device falls under product code GRZ (Antisera, Fluorescent, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Whittaker Bioproducts, Inc.

  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)
  • K913212 — 3M IGE SINGLE POINT FAST TEST (November 22, 1991)
  • K904652 — LYME STAT M TEST KIT (October 21, 1991)
  • K904893 — FIAX LYME M TEST KIT (October 16, 1991)
  • K911473 — EBNA STAT TEST KIT (September 25, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)
  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)

Other clearances for product code GRZ

  • K946373 — MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM (February 7, 1996)
  • 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)

FDA data resources