510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093631Substantially Equivalent

B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model Rf642 and Rf644

Siemens Healthcare Diagnostics Inc., Newark DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093631 is the FDA 510(k) clearance record for B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show no recalls naming K093631.

Clearance record

Decision date
Received
(80 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics 500 Gbc Dr., Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDD

Trailing 12 months

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

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