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FDA 510(k)

SUCROSEP THYROID STIMULATING HORMONE

K-Number: K842593 · 1984-09-12

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1984-09-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUCROSEP THYROID STIMULATING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-09-12 under 510(k) number K842593. 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 SUCROSEP THYROID STIMULATING HORMONE?

SUCROSEP THYROID STIMULATING HORMONE is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K842593.

When did SUCROSEP THYROID STIMULATING HORMONE receive FDA 510(k) clearance?

SUCROSEP THYROID STIMULATING HORMONE received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842593.

Who is the listed applicant for SUCROSEP THYROID STIMULATING HORMONE?

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

What is the FDA product code for SUCROSEP THYROID STIMULATING HORMONE?

The FDA product code for SUCROSEP THYROID STIMULATING HORMONE is JLW.

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Other records listing Boots-Celltech Diagnostics, Inc. as applicant

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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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