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FDA 510(k)

BIOCIRCUITS IOS T4 TEST CARTRIDGE

K-Number: K953837 · 1995-11-20

ApplicantBiocircuits Corp.
Decision Date1995-11-20
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCIRCUITS IOS T4 TEST CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuits Corp.. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K953837. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCIRCUITS IOS T4 TEST CARTRIDGE?

BIOCIRCUITS IOS T4 TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Biocircuits Corp.. The 510(k) number is K953837.

When did BIOCIRCUITS IOS T4 TEST CARTRIDGE receive FDA 510(k) clearance?

BIOCIRCUITS IOS T4 TEST CARTRIDGE received FDA 510(k) clearance on 1995-11-20, under 510(k) number K953837.

Who is the listed applicant for BIOCIRCUITS IOS T4 TEST CARTRIDGE?

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 T4 TEST CARTRIDGE?

The FDA product code for BIOCIRCUITS IOS T4 TEST CARTRIDGE is KLI.

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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 CONTROLSK952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

View all 8 devices →

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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