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FDA 510(k)

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT

K-Number: K854379 · 1986-01-07

ApplicantBioclinical Systems, Inc.
Decision Date1986-01-07
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1986-01-07 under 510(k) number K854379. 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 MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT?

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K854379.

When did MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT receive FDA 510(k) clearance?

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT received FDA 510(k) clearance on 1986-01-07, under 510(k) number K854379.

Who is the listed applicant for MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT?

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

What is the FDA product code for MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT?

The FDA product code for MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT is JLW.

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Other records listing Bioclinical Systems, 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.

K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIAK945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSK933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARK933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARK873086ROUND 1K860333MICRO-ELISA HLH TEST KIT MONOCLONAL

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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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