510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813242Substantially Equivalent

Quantimetric 2 Test Kit

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

K813242 is the FDA 510(k) clearance record for QUANTIMETRIC 2 TEST KIT, a class I device, cleared for Kallestad Laboratories, Inc. on under FDA product code KEW (Slides, Microscope). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K813242.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KEW Slides, Microscope
Regulation
21 CFR 864.3010
Device class
Class I
Review panel
Pathology
Applicant
Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEW

Trailing 12 months

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

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