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FDA 510(k)

SENTECH'S ULAB 1000 CLINICAL CHEM.

K-Number: K841575 · 1984-07-06

ApplicantSen Tech Medical Corp.
Decision Date1984-07-06
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENTECH'S ULAB 1000 CLINICAL CHEM. is the device name listed in this FDA 510(k) record. The listed applicant is Sen Tech Medical Corp.. It received FDA 510(k) clearance on 1984-07-06 under 510(k) number K841575. 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 SENTECH'S ULAB 1000 CLINICAL CHEM.?

SENTECH'S ULAB 1000 CLINICAL CHEM. is a medical device that received FDA 510(k) clearance on 1984-07-06. The listed applicant is Sen Tech Medical Corp.. The 510(k) number is K841575.

When did SENTECH'S ULAB 1000 CLINICAL CHEM. receive FDA 510(k) clearance?

SENTECH'S ULAB 1000 CLINICAL CHEM. received FDA 510(k) clearance on 1984-07-06, under 510(k) number K841575.

Who is the listed applicant for SENTECH'S ULAB 1000 CLINICAL CHEM.?

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

What is the FDA product code for SENTECH'S ULAB 1000 CLINICAL CHEM.?

The FDA product code for SENTECH'S ULAB 1000 CLINICAL CHEM. is CEM.

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Other records listing Sen Tech Medical 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.

K910071PORTA GAS COMPRESSED GAS CYLINDER CARTK855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSK854260CHEMPRO 1000K851100CHEM PRO 1000 CHEMISTRY ANALYSIS

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

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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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