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FDA 510(k)

FLUOROMETER, GENERAL USE

K-Number: K830624 · 1983-04-05

ApplicantAbbott Diagnostics
Decision Date1983-04-05
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUOROMETER, GENERAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830624. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROMETER, GENERAL USE?

FLUOROMETER, GENERAL USE is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Abbott Diagnostics. The 510(k) number is K830624.

When did FLUOROMETER, GENERAL USE receive FDA 510(k) clearance?

FLUOROMETER, GENERAL USE received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830624.

Who is the listed applicant for FLUOROMETER, GENERAL USE?

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 FLUOROMETER, GENERAL USE?

The FDA product code for FLUOROMETER, GENERAL USE is KHO.

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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: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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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