510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140001Unknown

Zinc Transporter 8 Antibody (Znt8ab) Elisa Assay Kit

Kronus Market Development Associates, Inc., Star ID / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN140001 is the FDA 510(k) clearance record for ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT, a class II device, cleared for Kronus Market Development Associates, Inc. on under FDA product code PHF (Zinc Transporter 8 Auto-Antibody). FDA's definition for product code PHF reads: "The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an...". FDA records list 11 510(k) clearances for Kronus Market Development Associates, Inc., from to . As of , FDA records show no recalls naming DEN140001.

Clearance record

Decision date
Received
(65 days to decision)
Product code
PHF Zinc Transporter 8 Auto-Antibody
Regulation
21 CFR 866.5670
Device class
Class II
Review panel
Immunology
Applicant
Kronus Market Development Associates, Inc. 170 S. Seneca Springs Way, Star ID
Third party review
No

Clearances, product code PHF

Trailing 12 months

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

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