510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941878Substantially Equivalent

Octeia Intact Pth

I.D.S., Tyne & Wear, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941878 is the FDA 510(k) clearance record for OCTEIA INTACT PTH, a class II device, cleared for I.D.S. on under FDA product code CEW (Radioimmunoassay, Parathyroid Hormone). FDA records list one 510(k) clearance for I.D.S. As of , FDA records show no recalls naming K941878.

Clearance record

Decision date
Received
(142 days to decision)
Product code
CEW Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Applicant
I.d.s. Boldon Business Park, Tyne & Wear, GB
510(k) summary
Statement
Third party review
No

Clearances, product code CEW

Trailing 12 months

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

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