510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063498Substantially Equivalent

Hydragel 18 A1at Isofocusing Kit (Pn 4356)

Sebia, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063498 is the FDA 510(k) clearance record for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356), a class II device, cleared for Sebia on under FDA product code OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype). FDA's definition for product code OBZ reads: "The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only". FDA records list one 510(k) clearance for Sebia. As of , FDA records show no recalls naming K063498.

Clearance record

Decision date
Received
(203 days to decision)
Product code
OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Sebia 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBZ

Trailing 12 months

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

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