510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862313Substantially Equivalent

Kallestad Sm/rnp Test Reagent

Kallestad Laboratories, Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862313 is the FDA 510(k) clearance record for KALLESTAD SM/RNP TEST REAGENT, a class II device, cleared for Kallestad Laboratories, Inc. on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K862313.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
Third party review
No

Clearances, product code LKJ

Trailing 12 months

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

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