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FDA 510(k)

DYNA-LYTE 2000

K-Number: K842786 · 1984-09-14

ApplicantAbbott Diagnostics
Decision Date1984-09-14
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNA-LYTE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K842786. 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 DYNA-LYTE 2000?

DYNA-LYTE 2000 is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Abbott Diagnostics. The 510(k) number is K842786.

When did DYNA-LYTE 2000 receive FDA 510(k) clearance?

DYNA-LYTE 2000 received FDA 510(k) clearance on 1984-09-14, under 510(k) number K842786.

Who is the listed applicant for DYNA-LYTE 2000?

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

What is the FDA product code for DYNA-LYTE 2000?

The FDA product code for DYNA-LYTE 2000 is CEM.

Other records listing Abbott Diagnostics 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENT

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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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