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FDA 510(k)

FLUORESCENCE DETECTOR MODEL 420

K-Number: K780031 · 1978-01-20

ApplicantWaters Assoc., Inc.
Decision Date1978-01-20
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUORESCENCE DETECTOR MODEL 420 is the device name listed in this FDA 510(k) record. The listed applicant is Waters Assoc., Inc.. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780031. 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 FLUORESCENCE DETECTOR MODEL 420?

FLUORESCENCE DETECTOR MODEL 420 is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K780031.

When did FLUORESCENCE DETECTOR MODEL 420 receive FDA 510(k) clearance?

FLUORESCENCE DETECTOR MODEL 420 received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780031.

Who is the listed applicant for FLUORESCENCE DETECTOR MODEL 420?

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

What is the FDA product code for FLUORESCENCE DETECTOR MODEL 420?

The FDA product code for FLUORESCENCE DETECTOR MODEL 420 is KHO.

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Other records listing Waters Assoc., 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.

K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOLK8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATHK801852MRM-2 OXYGEN CONSUMPTION MONITORK801431PAN-AM MYELOGRAM TRAYK791661SYSTEM CONTROLLER 720 SERIESK7910264F STERILE BALLOON-LESS, CATHETER 913-28

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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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