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FDA 510(k)

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS

K-Number: K961566 · 1996-11-18

ApplicantBiocircuits Corp.
Decision Date1996-11-18
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuits Corp.. It received FDA 510(k) clearance on 1996-11-18 under 510(k) number K961566. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS?

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is Biocircuits Corp.. The 510(k) number is K961566.

When did BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS receive FDA 510(k) clearance?

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS received FDA 510(k) clearance on 1996-11-18, under 510(k) number K961566.

Who is the listed applicant for BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS?

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 TSH TEST CARTRIDGES/THYROID CONTROLS?

The FDA product code for BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS is JLW.

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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 CONTROLSK961792BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLSK952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)K952751BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

View all 8 devices →

Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman 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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