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FDA 510(k)

MICROFLUOR READER

K-Number: K822772 · 1982-10-27

ApplicantDynatech Corp.
Decision Date1982-10-27
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROFLUOR READER is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Corp.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822772. 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 MICROFLUOR READER?

MICROFLUOR READER is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Dynatech Corp.. The 510(k) number is K822772.

When did MICROFLUOR READER receive FDA 510(k) clearance?

MICROFLUOR READER received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822772.

Who is the listed applicant for MICROFLUOR READER?

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

What is the FDA product code for MICROFLUOR READER?

The FDA product code for MICROFLUOR READER is KHO.

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Other records listing Dynatech 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.

K904567DYNATECH MR4000 MICROPLATE READERK854603MULTI MASH 2000K854602MINI MASH 2000K854604AUTO MASHK832117IMMULON SUBSTRATE REMOVAWELL STRIPSK823787HANDI-WASH

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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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