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FDA 510(k)

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT

K-Number: K930006 · 1993-09-09

ApplicantBio-Chem Laboratory Systems, Inc.
Decision Date1993-09-09
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Chem Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1993-09-09 under 510(k) number K930006. 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 AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT?

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT is a medical device that received FDA 510(k) clearance on 1993-09-09. The listed applicant is Bio-Chem Laboratory Systems, Inc.. The 510(k) number is K930006.

When did AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT receive FDA 510(k) clearance?

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT received FDA 510(k) clearance on 1993-09-09, under 510(k) number K930006.

Who is the listed applicant for AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT?

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

What is the FDA product code for AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT?

The FDA product code for AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT is JLW.

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Other records listing Bio-Chem Laboratory 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.

K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMK930689AUTOBEAD THYROID UPTAKEK926563AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KITK924084ATAC 6000 CHEMISTRY ANALYZER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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