Cascade M, Cat. No. 1710

FDA 510(k) K931956 · Helena Laboratories

Substantially Equivalent

510(k) numberK931956

Submission

Device name
Cascade M, Cat. No. 1710
Applicant
Helena Laboratories
Beaumont, TX, US
Received
April 20, 1993
Decision date
August 23, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GKP – Instrument, Coagulation, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5400
Specialty
Hematology

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Questions and answers

When was Cascade M, Cat. No. 1710 cleared by the FDA?

Cascade M, Cat. No. 1710 (K931956) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 125 days after the submission was received.

What is the product code of K931956?

The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.