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FDA 510(k)

ECLIPSE ICA TSH

K-Number: K910256 · 1991-02-22

ApplicantBiotope, Inc.
Decision Date1991-02-22
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA TSH is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-02-22 under 510(k) number K910256. 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 ECLIPSE ICA TSH?

ECLIPSE ICA TSH is a medical device that received FDA 510(k) clearance on 1991-02-22. The listed applicant is Biotope, Inc.. The 510(k) number is K910256.

When did ECLIPSE ICA TSH receive FDA 510(k) clearance?

ECLIPSE ICA TSH received FDA 510(k) clearance on 1991-02-22, under 510(k) number K910256.

Who is the listed applicant for ECLIPSE ICA TSH?

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

What is the FDA product code for ECLIPSE ICA TSH?

The FDA product code for ECLIPSE ICA TSH is JLW.

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Other records listing Biotope, 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.

K905145ECLIPSE ICA CHOLESTEROLK910302ECLIPSE ICA ANALYZERK905601ECLIPSE ICA TRIGLYCERIDESK905719ECLIPSE ICA DIGOXINK905602ECLIPSE ICA BUNK905144ECLIPSE ICA GLUCOSE

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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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