510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981931Substantially Equivalent

Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay

Roche Diagnostics/Boehringer Mannheim GmbH, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981931 is the FDA 510(k) clearance record for CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY, a class II device, cleared for Roche Diagnostics/Boehringer Mannheim GmbH on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 3 510(k) clearances for Roche Diagnostics/Boehringer Mannheim GmbH, from to . As of , FDA records show no recalls naming K981931.

Clearance record

Decision date
Received
(84 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/Boehringer Mannheim GmbH 4300 Hacienda Dr., Pleasanton CA
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