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FDA 510(k)

CHROMOLIZE PAI-1 KIT

K-Number: K963106 · 1996-11-18

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1996-11-18
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROMOLIZE PAI-1 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1996-11-18 under 510(k) number K963106. 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 CHROMOLIZE PAI-1 KIT?

CHROMOLIZE PAI-1 KIT is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K963106.

When did CHROMOLIZE PAI-1 KIT receive FDA 510(k) clearance?

CHROMOLIZE PAI-1 KIT received FDA 510(k) clearance on 1996-11-18, under 510(k) number K963106.

Who is the listed applicant for CHROMOLIZE PAI-1 KIT?

The FDA 510(k) record lists Medical Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOLIZE PAI-1 KIT?

The FDA product code for CHROMOLIZE PAI-1 KIT is GGP.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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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