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FDA 510(k)

DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE

K-Number: K970330 · 1997-04-14

ApplicantDade Intl., Inc.
Decision Date1997-04-14
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE 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 1997-04-14 under 510(k) number K970330. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE?

DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Dade Intl., Inc.. The 510(k) number is K970330.

When did DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE receive FDA 510(k) clearance?

DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE received FDA 510(k) clearance on 1997-04-14, under 510(k) number K970330.

Who is the listed applicant for DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE?

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 DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE?

The FDA product code for DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE is CEM.

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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: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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