Medicount Deka Hematology Analyzer

FDA 510(k) K942525 · Cea America Corp.

Substantially Equivalent

510(k) numberK942525

Submission

Device name
Medicount Deka Hematology Analyzer
Applicant
Cea America Corp.
Houston, TX, US
Received
May 27, 1994
Decision date
June 5, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GKZ – Counter, Differential Cell
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5220
Specialty
Hematology

Other 510(k)s with product code GKZ

510(k)DeviceApplicantDecision
K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional Sysmex America, Inc.05/27/2026SE
K243348Athelas HomeGKZ · Traditional Athelas, Inc.02/06/2026SE
K251249Tru Hematology TestGKZ · Traditional Truvian Sciences, Inc.01/16/2026SE
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K243283Alinity h-series SystemGKZ · Traditional Abbott Laboratories02/20/2025SE
K240402Cito CBC SystemGKZ · Dual Track Cytochip, Inc.02/03/2025SE
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional Beckman Coulter, Inc.07/05/2024SE
K232946Yumizen H2500GKZ · Traditional Horiba Abx SAS05/21/2024SE
K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated Pixcell Medical Technologies05/02/2024SE

More from Pixcell Medical Technologies

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K834613Wilcor-Xr RP Medical FilmIWZ · Traditional 03/05/1984SE
K834612Wilcor-Xr Rp-Og Medical FilmIWZ · Traditional 02/27/1984SE
K834611Singul-Xr RP Non Screen Med. FilmIWZ · Traditional 02/21/1984SE

Questions and answers

When was Medicount Deka Hematology Analyzer cleared by the FDA?

Medicount Deka Hematology Analyzer (K942525) received a 510(k) decision of Substantially Equivalent on June 5, 1996, 740 days after the submission was received.

What is the product code of K942525?

The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.