510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791740Substantially Equivalent

Serum 11-Desoxycortisol I as Tracer

Radioassay Systems Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791740 is the FDA 510(k) clearance record for SERUM 11-DESOXYCORTISOL I AS TRACER, a class I device, cleared for Radioassay Systems Laboratories, Inc. on under FDA product code JKB (Radioimmunoassay, Compound S (11-Deoxycortisol)). FDA records list 15 510(k) clearances for Radioassay Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K791740.

Clearance record

Decision date
Received
(17 days to decision)
Product code
JKB Radioimmunoassay, Compound S (11-Deoxycortisol)
Regulation
21 CFR 862.1185
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Radioassay Systems Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKB

Trailing 12 months

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

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