510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050758Substantially Equivalent

Chempaq Xbc Analyzer

Chempaq A/S, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050758 is the FDA 510(k) clearance record for CHEMPAQ XBC ANALYZER, a class II device, cleared for Chempaq A/S on under FDA product code GKZ (Counter, Differential Cell). FDA records list 2 510(k) clearances for Chempaq A/S, from to . As of , FDA records show no recalls naming K050758.

Clearance record

Decision date
Received
(274 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Chempaq A/S 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260