Autolyzer 801 System (Automated Cell Counter)

FDA 510(k) K875346 · Contraves Medical Instruments, Inc.

Substantially Equivalent

510(k) numberK875346

Submission

Device name
Autolyzer 801 System (Automated Cell Counter)
Applicant
Contraves Medical Instruments, Inc.
Billerica, MA, US
Received
December 31, 1987
Decision date
April 7, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
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K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated Pixcell Medical Technologies05/02/2024SE

More from Pixcell Medical Technologies

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K873271Digicell 300 SystemGKL · Traditional 11/06/1987SE
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Questions and answers

When was Autolyzer 801 System (Automated Cell Counter) cleared by the FDA?

Autolyzer 801 System (Automated Cell Counter) (K875346) received a 510(k) decision of Substantially Equivalent on April 7, 1988, 98 days after the submission was received.

What is the product code of K875346?

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