Home / 510(k) Clearances / K840012

510(k) K840012

INDIRECT FLUORESCENT ANTIBODY MYCO by Zeus Technologies — Product Code GRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
January 4, 1984
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 Zeus Technologies

  • K831026 — INDIRECT FLUORESCENT ANTIBODY REAGENTS (June 22, 1983)
  • K830783 — VERI-STAPH (April 8, 1983)
  • K822859 — DIRECT FA CONJUGATE FOR LEGIONELLA SPP (February 16, 1983)

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)
  • K861716 — FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY (August 8, 1986)