Tri-Count Laser

FDA 510(k) K843485 · Hematology Marketing Assoc.

Substantially Equivalent

510(k) numberK843485

Submission

Device name
Tri-Count Laser
Applicant
Hematology Marketing Assoc.
Concord, CA, US
Received
September 6, 1984
Decision date
December 12, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JPK – Mixture, Hematology Quality Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

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More from R&D Systems, Inc.

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K851843Osmocel 3GIF · Traditional 07/30/1985SE
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K844708Tri-Count CalibratorKSA · Traditional 03/05/1985SE
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K831306HemacalKRZ · Traditional 06/16/1983SE

Questions and answers

When was Tri-Count Laser cleared by the FDA?

Tri-Count Laser (K843485) received a 510(k) decision of Substantially Equivalent on December 12, 1984, 97 days after the submission was received.

What is the product code of K843485?

The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.