510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840257Substantially Equivalent

Rapid Immuno-Assay Sys

Applied Polytechnology, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840257 is the FDA 510(k) clearance record for RAPID IMMUNO-ASSAY SYS, a class II device, cleared for Applied Polytechnology, Inc. on under FDA product code LLG (Kit, Igg, Platelet Associated). FDA records list 7 510(k) clearances for Applied Polytechnology, Inc., from to . As of , FDA records show no recalls naming K840257.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LLG Kit, Igg, Platelet Associated
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Applied Polytechnology, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LLG

Trailing 12 months

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

FDA records show no clearances under product code LLG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLG, 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