N-Tact(R) PTH SP Kit

FDA 510(k) K921629 · Incstar Corp.

Substantially Equivalent

510(k) numberK921629

Submission

Device name
N-Tact(R) PTH SP Kit
Applicant
Incstar Corp.
Stillwater, MN, US
Received
April 6, 1992
Decision date
May 14, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CEW – Radioimmunoassay, Parathyroid Hormone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1545
Specialty
Clinical Chemistry

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Questions and answers

When was N-Tact(R) PTH SP Kit cleared by the FDA?

N-Tact(R) PTH SP Kit (K921629) received a 510(k) decision of Substantially Equivalent on May 14, 1992, 38 days after the submission was received.

What is the product code of K921629?

The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.