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FDA 510(k)

ALDETECT

K-Number: K905779 · 1991-05-23

ApplicantPochemco, Inc.
Decision Date1991-05-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALDETECT is the device name listed in this FDA 510(k) record. The listed applicant is Pochemco, Inc.. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K905779. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALDETECT?

ALDETECT is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Pochemco, Inc.. The 510(k) number is K905779.

When did ALDETECT receive FDA 510(k) clearance?

ALDETECT received FDA 510(k) clearance on 1991-05-23, under 510(k) number K905779.

Who is the listed applicant for ALDETECT?

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

What is the FDA product code for ALDETECT?

The FDA product code for ALDETECT is FJI.

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Official Source

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

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