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FDA 510(k)

ACETAMINOPHEN FLEX REAGENT CARTRIDGE

K-Number: K963244 · 1996-09-23

ApplicantDade Intl., Inc.
Decision Date1996-09-23
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETAMINOPHEN FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K963244. 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 FLEX REAGENT CARTRIDGE?

ACETAMINOPHEN FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Dade Intl., Inc.. The 510(k) number is K963244.

When did ACETAMINOPHEN FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

ACETAMINOPHEN FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1996-09-23, under 510(k) number K963244.

Who is the listed applicant for ACETAMINOPHEN FLEX REAGENT CARTRIDGE?

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

What is the FDA product code for ACETAMINOPHEN FLEX REAGENT CARTRIDGE?

The FDA product code for ACETAMINOPHEN FLEX REAGENT CARTRIDGE is LDP.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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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