510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080016Substantially Equivalent

Nrbc-Chex for Advia

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

K080016 is the FDA 510(k) clearance record for NRBC-CHEX FOR ADVIA, a class II device, cleared for Streck on under FDA product code GJR (Control, Red-Cell). FDA records list 38 510(k) clearances for Streck, from to . As of , FDA records show no recalls naming K080016.

Clearance record

Decision date
Received
(33 days to decision)
Product code
GJR Control, Red-Cell
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Streck 7002 S 109th St., La Vista NE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GJR

Trailing 12 months

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

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