510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K813530Substantially Equivalent

Hemotology Calibrator

American Dade, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813530 is the FDA 510(k) clearance record for HEMOTOLOGY CALIBRATOR, a class II device, cleared for American Dade on under FDA product code KSA (Calibrator For Red-Cell And White-Cell Counting). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K813530.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KSA Calibrator For Red-Cell And White-Cell Counting
Regulation
21 CFR 864.8185
Device class
Class II
Review panel
Hematology
Applicant
American Dade 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KSA

Trailing 12 months

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

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