Clearplan

FDA 510(k) K871332 · Unipath , Ltd.

Substantially Equivalent

510(k) numberK871332

Submission

Device name
Clearplan
Applicant
Unipath , Ltd.
Bedford Mk41 Oqg, GB
Received
April 3, 1987
Decision date
August 5, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CEP – Radioimmunoassay, Luteinizing Hormone
Device class
Class I (low risk)
Regulation
21 CFR 862.1485
Specialty
Clinical Chemistry

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Questions and answers

When was Clearplan cleared by the FDA?

Clearplan (K871332) received a 510(k) decision of Substantially Equivalent on August 5, 1987, 124 days after the submission was received.

What is the product code of K871332?

The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.