510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950292Substantially Equivalent

Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System

Miles, Inc., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950292 is the FDA 510(k) clearance record for FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM, a class II device, cleared for Miles, Inc. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 11 510(k) clearances for Miles, Inc., from to . As of , FDA records show no recalls naming K950292.

Clearance record

Decision date
Received
(97 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Miles, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code CGN

Trailing 12 months

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

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