510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840103Substantially Equivalent

Radioimmunoassay for Total Ige Human

Techniclone Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840103 is the FDA 510(k) clearance record for RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN, a class II device, cleared for Techniclone Intl. on under FDA product code JHR (Radioimmunoassay, Immunoglobulins (D, E)). FDA records list one 510(k) clearance for Techniclone Intl. As of , FDA records show no recalls naming K840103.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JHR Radioimmunoassay, Immunoglobulins (D, E)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Techniclone Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JHR

Trailing 12 months

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

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