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FDA 510(k)

GLUTATECT

K-Number: K971888 · 1998-01-09

ApplicantAlden Scientific, Inc.
Decision Date1998-01-09
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUTATECT is the device name listed in this FDA 510(k) record. The listed applicant is Alden Scientific, Inc.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K971888. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUTATECT?

GLUTATECT is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Alden Scientific, Inc.. The 510(k) number is K971888.

When did GLUTATECT receive FDA 510(k) clearance?

GLUTATECT received FDA 510(k) clearance on 1998-01-09, under 510(k) number K971888.

Who is the listed applicant for GLUTATECT?

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

What is the FDA product code for GLUTATECT?

The FDA product code for GLUTATECT is JOJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Alden Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934066NEPHRETECT

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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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