510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935286Substantially Equivalent

Quantaphase II B12/folate

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935286 is the FDA 510(k) clearance record for QUANTAPHASE II B12/FOLATE, a class II device, cleared for Bio-Rad on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K935286.

Clearance record

Decision date
Received
(137 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260