510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843365Substantially Equivalent

ISO-Data Immunoassay Network System

Iso-Data, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843365 is the FDA 510(k) clearance record for ISO-DATA IMMUNOASSAY NETWORK SYSTEM, a class I device, cleared for Iso-Data, Inc. on under FDA product code JQP (Calculator/Data Processing Module, For Clinical Use). FDA records list 7 510(k) clearances for Iso-Data, Inc., from to . As of , FDA records show no recalls naming K843365.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Regulation
21 CFR 862.2100
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Iso-Data, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JQP

Trailing 12 months

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

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