Quanticel-Hrp

FDA 510(k) K781247 · Bhp Diagnostix, Inc.

Substantially Equivalent

510(k) numberK781247

Submission

Device name
Quanticel-Hrp
Applicant
Bhp Diagnostix, Inc.
Mchenry, IL, US
Received
July 21, 1978
Decision date
September 14, 1978
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 Quanticel-Hrp cleared by the FDA?

Quanticel-Hrp (K781247) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 55 days after the submission was received.

What is the product code of K781247?

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