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FDA 510(k)

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001

K-Number: K991146 · 1999-06-22

ApplicantBiocheck, Inc.
Decision Date1999-06-22
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K991146. 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 TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001?

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Biocheck, Inc.. The 510(k) number is K991146.

When did TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 receive FDA 510(k) clearance?

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 received FDA 510(k) clearance on 1999-06-22, under 510(k) number K991146.

Who is the listed applicant for TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001?

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

What is the FDA product code for TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001?

The FDA product code for TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 is JLW.

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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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