510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831242Substantially Equivalent

Lithium Heparinized Blood Collect-Tube

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

K831242 is the FDA 510(k) clearance record for LITHIUM HEPARINIZED BLOOD COLLECT-TUBE, a class II device, cleared for American Dade on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K831242.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
American Dade 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260