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FDA 510(k)

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

K-Number: K050448 · 2005-09-23

ApplicantHoriba Abx
Decision Date2005-09-23
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2005-09-23 under 510(k) number K050448. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5?

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 is a medical device that received FDA 510(k) clearance on 2005-09-23. The listed applicant is Horiba Abx. The 510(k) number is K050448.

When did CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 receive FDA 510(k) clearance?

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 received FDA 510(k) clearance on 2005-09-23, under 510(k) number K050448.

Who is the listed applicant for CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5?

The FDA 510(k) record lists Horiba Abx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5?

The FDA product code for CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 is GGP.

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Related Devices (Code: GGP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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