510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K102510Substantially Equivalent

Dimensions Hb1c Kit, Model Df105a

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

K102510 is the FDA 510(k) clearance record for DIMENSIONS HB1C KIT, MODEL DF105A, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show one recall naming K102510.

Clearance record

Decision date
Received
(259 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Siemens Healthcare Diagnostics 500 Gbc Dr., Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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