Hematology Control Uni-Cell 5, Uni-Cell 7 & 8

FDA 510(k) K844897 · Medical Specialties Laboratories

Substantially Equivalent

510(k) numberK844897

Submission

Device name
Hematology Control Uni-Cell 5, Uni-Cell 7 & 8
Applicant
Medical Specialties Laboratories
Boston, MA, US
Received
December 17, 1984
Decision date
March 22, 1985
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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Questions and answers

When was Hematology Control Uni-Cell 5, Uni-Cell 7 & 8 cleared by the FDA?

Hematology Control Uni-Cell 5, Uni-Cell 7 & 8 (K844897) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 95 days after the submission was received.

What is the product code of K844897?

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