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FDA 510(k)

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.

K-Number: K981059 · 1998-05-12

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-05-12
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K981059. 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 ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.?

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K981059.

When did ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. receive FDA 510(k) clearance?

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. received FDA 510(k) clearance on 1998-05-12, under 510(k) number K981059.

Who is the listed applicant for ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.?

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

What is the FDA product code for ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.?

The FDA product code for ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. is LDP.

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Other records listing Diagnostic Chemicals , Ltd. 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.

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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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