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FDA 510(k)

ACETASITE

K-Number: K931257 · 1993-07-08

ApplicantGds Diagnostics
Decision Date1993-07-08
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETASITE is the device name listed in this FDA 510(k) record. The listed applicant is Gds Diagnostics. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K931257. 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 ACETASITE?

ACETASITE is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Gds Diagnostics. The 510(k) number is K931257.

When did ACETASITE receive FDA 510(k) clearance?

ACETASITE received FDA 510(k) clearance on 1993-07-08, under 510(k) number K931257.

Who is the listed applicant for ACETASITE?

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

What is the FDA product code for ACETASITE?

The FDA product code for ACETASITE is LDP.

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Other records listing Gds Diagnostics 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.

K910881CONTROL AND LINEARITYK910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDK891761GDS ENZYMATIC THEOPHYLLINE REAGENT

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

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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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