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510(k) K853697

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT by Biostar Medical Products, Inc. — Product Code DAK

K853697 is an FDA 510(k) premarket notification submitted by Biostar Medical Products, Inc. for the device "BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 16, 1985. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Biostar Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1985
Date Received
September 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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)
  • K863238 — READS RF TEST KIT FOR IGM RHEUMATOID FACTOR (October 8, 1986)
  • K861499 — BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (June 20, 1986)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI (September 30, 1998)
  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K914388 — C1 RID KIT (October 28, 1991)
  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K864312 — IC MICROASSAY (January 9, 1987)

FDA data resources