510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950510Substantially Equivalent

Octeia Igf-1 Kit

Immunodiagnostic Systems Ltd., Tyne And Wear, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950510 is the FDA 510(k) clearance record for OCTEIA IGF-1 KIT, a class I device, cleared for Immunodiagnostic Systems , Ltd. on under FDA product code CFL (Radioimmunoassay, Human Growth Hormone). FDA records list 27 510(k) clearances for Immunodiagnostic Systems , Ltd., from to . As of , FDA records show no recalls naming K950510.

Clearance record

Decision date
Received
(58 days to decision)
Product code
CFL Radioimmunoassay, Human Growth Hormone
Regulation
21 CFR 862.1370
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immunodiagnostic Systems , Ltd. Bolden Business Park, Tyne And Wear, GB
510(k) summary
Statement
Third party review
No

Clearances, product code CFL

Trailing 12 months

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

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