510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031359Substantially Equivalent

S-Monovette Edta K2-Gel

Sarstedt ApS, Newton NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031359 is the FDA 510(k) clearance record for S-MONOVETTE EDTA K2-GEL, a class II device, cleared for Sarstedt, 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 6 510(k) clearances for Sarstedt, Inc., from to . As of , FDA records show no recalls naming K031359.

Clearance record

Decision date
Received
(135 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
Sarstedt, Inc. 1025 St. James Church Rd., Newton NC
510(k) summary
Statement
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