510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200001Unknown

Cell-Free DNA BCT

Streck LLC, La Vista NE / Direct, Unknown
FDA source (opens on fda.gov)

DEN200001 is the FDA 510(k) clearance record for Cell-Free DNA BCT, a class II device, cleared for Streck, Inc. on under FDA product code QMA (Blood Collection Device For Cell-Free Nucleic Acid). FDA's definition for product code QMA reads: "A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing". FDA records list 38 510(k) clearances for Streck, Inc., from to . As of , FDA records show no recalls naming DEN200001.

Clearance record

Decision date
Received
(210 days to decision)
Product code
QMA Blood Collection Device For Cell-Free Nucleic Acid
Regulation
21 CFR 862.1676
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Streck, Inc. 7002 S 109th St., La Vista NE
Third party review
No

Clearances, product code QMA

Trailing 12 months

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

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