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FDA 510(k)

CYBERFLUOR 615 IMMUNOANALYZER

K-Number: K872803 · 1987-09-02

ApplicantCyberfluor, Inc.
Decision Date1987-09-02
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYBERFLUOR 615 IMMUNOANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1987-09-02 under 510(k) number K872803. 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 CYBERFLUOR 615 IMMUNOANALYZER?

CYBERFLUOR 615 IMMUNOANALYZER is a medical device that received FDA 510(k) clearance on 1987-09-02. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K872803.

When did CYBERFLUOR 615 IMMUNOANALYZER receive FDA 510(k) clearance?

CYBERFLUOR 615 IMMUNOANALYZER received FDA 510(k) clearance on 1987-09-02, under 510(k) number K872803.

Who is the listed applicant for CYBERFLUOR 615 IMMUNOANALYZER?

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

What is the FDA product code for CYBERFLUOR 615 IMMUNOANALYZER?

The FDA product code for CYBERFLUOR 615 IMMUNOANALYZER is KHO.

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Other records listing Cyberfluor, 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.

K923410FIAGEN PROGESTERONEK905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSH

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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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