Chromopep PC, Chromopep at, Models 2.5 and 5

FDA 510(k) K050448 · Horiba Abx

Substantially Equivalent

510(k) numberK050448

Submission

Device name
Chromopep PC, Chromopep at, Models 2.5 and 5
Applicant
Horiba Abx
Montpellier, FR
Received
February 22, 2005
Decision date
September 23, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Chromopep PC, Chromopep at, Models 2.5 and 5 cleared by the FDA?

Chromopep PC, Chromopep at, Models 2.5 and 5 (K050448) received a 510(k) decision of Substantially Equivalent on September 23, 2005, 213 days after the submission was received.

What is the product code of K050448?

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