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510(k) K931557

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST by Fuller Laboratories, Inc. — Product Code GRZ

K931557 is an FDA 510(k) premarket notification submitted by Fuller Laboratories, Inc. for the device "FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code GRZ (Antisera, Fluorescent, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Fuller Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
March 30, 1993
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 Fuller Laboratories, Inc.

  • K925690 — MERIDIAN EBNA TEST KIT (October 12, 1993)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)
  • K925688 — MERIDIAN EBV-EA TEST KIT (October 12, 1993)

Other clearances for product code GRZ

  • K946373 — MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM (February 7, 1996)
  • K944417 — ZEUA MYCOPLASMA (August 1, 1995)
  • K861716 — FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY (August 8, 1986)
  • K840012 — INDIRECT FLUORESCENT ANTIBODY MYCO (February 27, 1984)

FDA data resources