510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014104Substantially Equivalent

Vacuette Edta K2 Tubes

Greiner Bio-One North America, Inc., Baldwin MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014104 is the FDA 510(k) clearance record for VACUETTE EDTA K2 TUBES, a class II device, cleared for Greiner Vacuette North America, Inc. on under FDA product code PJE (Blood/Plasma Collection Device For Dna Testing). FDA's definition for product code PJE reads: "A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing". FDA records list 15 510(k) clearances for GREINER BIO-ONE NORTH AMERICA, INC., from to . As of , FDA records show no recalls naming K014104.

Clearance record

Decision date
Received
(50 days to decision)
Product code
PJE Blood/Plasma Collection Device For Dna Testing
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Greiner Vacuette North America, Inc. P.O.Box 103, Baldwin MD
510(k) summary
Summary
Third party review
No

Clearances, product code PJE

Trailing 12 months

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

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