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FDA 510(k)

ACETAMINOPHER ASSAY KIT

K-Number: K832045 · 1983-10-04

ApplicantQuantimetrix Corp.
Decision Date1983-10-04
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETAMINOPHER ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832045. 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 ACETAMINOPHER ASSAY KIT?

ACETAMINOPHER ASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Quantimetrix Corp.. The 510(k) number is K832045.

When did ACETAMINOPHER ASSAY KIT receive FDA 510(k) clearance?

ACETAMINOPHER ASSAY KIT received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832045.

Who is the listed applicant for ACETAMINOPHER ASSAY KIT?

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

What is the FDA product code for ACETAMINOPHER ASSAY KIT?

The FDA product code for ACETAMINOPHER ASSAY KIT is LDP.

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Other records listing Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

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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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