Msi-Diff Plus

FDA 510(k) K880270 · Medical Specialties, Inc.

Substantially Equivalent

510(k) numberK880270

Submission

Device name
Msi-Diff Plus
Applicant
Medical Specialties, Inc.
South Plainfield, NJ, US
Received
January 21, 1988
Decision date
March 1, 1988
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 Msi-Diff Plus cleared by the FDA?

Msi-Diff Plus (K880270) received a 510(k) decision of Substantially Equivalent on March 1, 1988, 40 days after the submission was received.

What is the product code of K880270?

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