Hematology Control

FDA 510(k) K760162 · Biological Corp. of America

Substantially Equivalent

510(k) numberK760162

Submission

Device name
Hematology Control
Applicant
Biological Corp. of America
Mchenry, IL, US
Received
July 6, 1976
Decision date
August 4, 1976
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 cleared by the FDA?

Hematology Control (K760162) received a 510(k) decision of Substantially Equivalent on August 4, 1976, 29 days after the submission was received.

What is the product code of K760162?

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