Digicell 300 System

FDA 510(k) K873271 · Contraves Medical Instruments, Inc.

Substantially Equivalent

510(k) numberK873271

Submission

Device name
Digicell 300 System
Applicant
Contraves Medical Instruments, Inc.
Billerica, MA, US
Received
August 17, 1987
Decision date
November 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKL – Counter, Cell, Automated (Particle Counter)
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Specialty
Hematology

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More from Sysmex Corp.

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K875346Autolyzer 801 System (Automated Cell Counter)GKZ · Traditional 04/07/1988SE
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Questions and answers

When was Digicell 300 System cleared by the FDA?

Digicell 300 System (K873271) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 81 days after the submission was received.

What is the product code of K873271?

The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.