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FDA 510(k)

BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

K-Number: K952719 · 1995-11-22

ApplicantBiocircuits Corp.
Decision Date1995-11-22
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCIRCUITS IOS (IN-OFFICE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuits Corp.. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K952719. 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 BIOCIRCUITS IOS (IN-OFFICE SYSTEM)?

BIOCIRCUITS IOS (IN-OFFICE SYSTEM) is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Biocircuits Corp.. The 510(k) number is K952719.

When did BIOCIRCUITS IOS (IN-OFFICE SYSTEM) receive FDA 510(k) clearance?

BIOCIRCUITS IOS (IN-OFFICE SYSTEM) received FDA 510(k) clearance on 1995-11-22, under 510(k) number K952719.

Who is the listed applicant for BIOCIRCUITS IOS (IN-OFFICE SYSTEM)?

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

What is the FDA product code for BIOCIRCUITS IOS (IN-OFFICE SYSTEM)?

The FDA product code for BIOCIRCUITS IOS (IN-OFFICE SYSTEM) is KHO.

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Other records listing Biocircuits 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.

K981634BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLSK980819BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLSK963770BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLSK961566BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLSK961792BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLSK953837BIOCIRCUITS IOS T4 TEST CARTRIDGE

View all 8 devices →

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.K950415FLUOROSCAN NEONATALIsolab, Inc.K935047AUTO DELFIAWallac OY

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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