Cal-Chex CD Plus

FDA 510(k) K020469 · Streck Laboratories, Inc.

Substantially Equivalent

510(k) numberK020469

Submission

Device name
Cal-Chex CD Plus
Applicant
Streck Laboratories, Inc.
La Vista, NE, US
Received
February 12, 2002
Decision date
April 4, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRX – Calibrator For Cell Indices
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8150
Specialty
Hematology

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Questions and answers

When was Cal-Chex CD Plus cleared by the FDA?

Cal-Chex CD Plus (K020469) received a 510(k) decision of Substantially Equivalent on April 4, 2002, 51 days after the submission was received.

What is the product code of K020469?

The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.