510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881933Substantially Equivalent

Kallestad Quantafluor Antithyroid Antibody Test

Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881933 is the FDA 510(k) clearance record for KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST, a class II device, cleared for Kallestad Diag, A Div. of Erbamont, Inc. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 58 510(k) clearances for Kallestad Diag, A Div. of Erbamont, Inc., from to . As of , FDA records show no recalls naming K881933.

Clearance record

Decision date
Received
(27 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Diag, A Div. of Erbamont, Inc. 2000 Lake Hazeltine Dr., Chaska MN
Third party review
No

Clearances, product code JZO

Trailing 12 months

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

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