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510(k) K893897

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM by Biostar Medical Products, Inc. — Product Code LKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
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)
  • K863238 — READS RF TEST KIT FOR IGM RHEUMATOID FACTOR (October 8, 1986)
  • 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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  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)