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FDA 510(k)

FLUOROMATIC ANALYZER AND AUTOSAMPLER

K-Number: K791329 · 1979-07-30

ApplicantBio-Rad
Decision Date1979-07-30
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUOROMATIC ANALYZER AND AUTOSAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K791329. 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 FLUOROMATIC ANALYZER AND AUTOSAMPLER?

FLUOROMATIC ANALYZER AND AUTOSAMPLER is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Bio-Rad. The 510(k) number is K791329.

When did FLUOROMATIC ANALYZER AND AUTOSAMPLER receive FDA 510(k) clearance?

FLUOROMATIC ANALYZER AND AUTOSAMPLER received FDA 510(k) clearance on 1979-07-30, under 510(k) number K791329.

Who is the listed applicant for FLUOROMATIC ANALYZER AND AUTOSAMPLER?

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

What is the FDA product code for FLUOROMATIC ANALYZER AND AUTOSAMPLER?

The FDA product code for FLUOROMATIC ANALYZER AND AUTOSAMPLER is KHO.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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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