510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861499Substantially Equivalent

Biostar* Reads* Immune Complex Assay Kit

Biostar Medical Products, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861499 is the FDA 510(k) clearance record for BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT, a class II device, cleared for Biostar Medical Products, Inc. on under FDA product code DAK (Complement C1q, Antigen, Antiserum, Control). FDA records list 5 510(k) clearances for Biostar Medical Products, Inc., from to . As of , FDA records show no recalls naming K861499.

Clearance record

Decision date
Received
(58 days to decision)
Product code
DAK Complement C1q, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Biostar Medical Products, Inc. Jerry W. Berkstresser, Denver CO
Third party review
No

Clearances, product code DAK

Trailing 12 months

FDA records hold no clearances under product code DAK in the trailing twelve months.

FDA records show no clearances under product code DAK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260