Spectrolyse Factor Vii:C

FDA 510(k) K934584 · Meditech, Inc.

Substantially Equivalent

510(k) numberK934584

Submission

Device name
Spectrolyse Factor Vii:C
Applicant
Meditech, Inc.
Ventura, CA, US
Received
September 23, 1993
Decision date
December 6, 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
GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

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Questions and answers

When was Spectrolyse Factor Vii:C cleared by the FDA?

Spectrolyse Factor Vii:C (K934584) received a 510(k) decision of Substantially Equivalent on December 6, 1993, 74 days after the submission was received.

What is the product code of K934584?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.