510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053497Substantially Equivalent

Guava Ezcd4 System

Guava Technologies, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053497 is the FDA 510(k) clearance record for GUAVA EZCD4 SYSTEM, a class II device, cleared for Guava Technologies, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Guava Technologies, Inc. As of , FDA records show no recalls naming K053497.

Clearance record

Decision date
Received
(120 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Guava Technologies, Inc. 25801 Industrial Blvd., Hayward CA
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