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FDA 510(k)

GDS ENZYMATIC ACETAMINOPHEN REAGENT

K-Number: K880829 · 1988-05-27

ApplicantGds Technology, LLC
Decision Date1988-05-27
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GDS ENZYMATIC ACETAMINOPHEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology, LLC. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K880829. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDS ENZYMATIC ACETAMINOPHEN REAGENT?

GDS ENZYMATIC ACETAMINOPHEN REAGENT is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Gds Technology, LLC. The 510(k) number is K880829.

When did GDS ENZYMATIC ACETAMINOPHEN REAGENT receive FDA 510(k) clearance?

GDS ENZYMATIC ACETAMINOPHEN REAGENT received FDA 510(k) clearance on 1988-05-27, under 510(k) number K880829.

Who is the listed applicant for GDS ENZYMATIC ACETAMINOPHEN REAGENT?

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

What is the FDA product code for GDS ENZYMATIC ACETAMINOPHEN REAGENT?

The FDA product code for GDS ENZYMATIC ACETAMINOPHEN REAGENT is LDP.

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Other records listing Gds Technology, LLC 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.

K994073HEMOSITE TEST SYSTEMK992132CHOLESITE TEST SYSTEMK973649HEMOSITE TEST SYSTEMK971145GLUCOSITE TEST SYSTEMK911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONK882038GDS ENZYMATIC SALICYLATE REAGENT

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Related Devices (Code: LDP)

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.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.K110726ROCHE ACETAMINOPHEN ASSAYRoche DiagnosticsK100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare DiagnosticsK081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.

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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