510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043318Substantially Equivalent

Modification to Roche Elecsys Folate II Immunoassay

Roche Diagnostics GmbH, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043318 is the FDA 510(k) clearance record for MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show one recall naming K043318.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
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