510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100307Substantially Equivalent

Gelscan, Model 1206

Sebia, Inc., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K100307 is the FDA 510(k) clearance record for GELSCAN, MODEL 1206, a class II device, cleared for Sebia on under FDA product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes). FDA records list 25 510(k) clearances for Sebia, from to . As of , FDA records show no recalls naming K100307.

Clearance record

Decision date
Received
(209 days to decision)
Product code
CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sebia 1705 Corporate Dr., Suite 400, Norcross GA
510(k) summary
Statement
Third party review
No

Clearances, product code CFE

Trailing 12 months

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

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