510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080552Substantially Equivalent

Cyto-Chex Bct

Streck LLC, La Vista NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080552 is the FDA 510(k) clearance record for CYTO-CHEX BCT, a class II device, cleared for Streck on under FDA product code GIM (Tubes, Vacuum Sample, With Anticoagulant). FDA records list 38 510(k) clearances for Streck, from to . As of , FDA records show one recall naming K080552.

Clearance record

Decision date
Received
(154 days to decision)
Product code
GIM Tubes, Vacuum Sample, With Anticoagulant
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Streck 7002 S 109th St., La Vista NE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GIM

Trailing 12 months

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

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