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510(k) K893897

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

K893897 is an FDA 510(k) premarket notification submitted by Biostar Medical Products, Inc. for the device "SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Biostar Medical Products, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code LKJ

  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K113610 — ANA-SCREEN WITH MDSS (July 9, 2012)
  • K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMU (April 10, 2009)
  • K081104 — AESKULISA ANA HEP-2, REF 30-7115US (May 2, 2008)
  • K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL (December 20, 2004)
  • K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM (October 8, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (May 12, 2003)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)
  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)

FDA data resources