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FDA 510(k)

SPECTROLYSE PAI-1, MODEL 101201

K-Number: K063323 · 2007-08-15

ApplicantAmerican Diagnostica, Inc.
Decision Date2007-08-15
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE PAI-1, MODEL 101201 is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K063323. 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 SPECTROLYSE PAI-1, MODEL 101201?

SPECTROLYSE PAI-1, MODEL 101201 is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K063323.

When did SPECTROLYSE PAI-1, MODEL 101201 receive FDA 510(k) clearance?

SPECTROLYSE PAI-1, MODEL 101201 received FDA 510(k) clearance on 2007-08-15, under 510(k) number K063323.

Who is the listed applicant for SPECTROLYSE PAI-1, MODEL 101201?

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

What is the FDA product code for SPECTROLYSE PAI-1, MODEL 101201?

The FDA product code for SPECTROLYSE PAI-1, MODEL 101201 is 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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