510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925468Unknown

Jj Skinner Carekits(tm) Blood Collection Kit

J.J. Skinner, Inc., Great Neck NY / Traditional, Unknown
FDA source (opens on fda.gov)

K925468 is the FDA 510(k) clearance record for JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT, a class II device, cleared for J.J. Skinner, Inc. on under FDA product code GJE (Tray, Blood Collection). FDA records list 7 510(k) clearances for J.J. Skinner, Inc., from to . As of , FDA records show no recalls naming K925468.

Clearance record

Decision date
Received
(529 days to decision)
Product code
GJE Tray, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
J.J. Skinner, Inc. C/O Medical Device Inspection, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code GJE

Trailing 12 months

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

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