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510(k) K863238

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR by Biostar Medical Products, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1986
Date Received
August 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Biostar Medical Products, Inc.

  • K893896 — QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA (July 14, 1989)
  • K893897 — SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM (June 23, 1989)
  • K861499 — BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (June 20, 1986)
  • K853697 — BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT (December 16, 1985)

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