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FDA 510(k)

THYROID STIMULATING HORMONE METHOD

K-Number: K970393 · 1997-03-03

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-03-03
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROID STIMULATING HORMONE METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-03-03 under 510(k) number K970393. 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 THYROID STIMULATING HORMONE METHOD?

THYROID STIMULATING HORMONE METHOD is a medical device that received FDA 510(k) clearance on 1997-03-03. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K970393.

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

THYROID STIMULATING HORMONE METHOD received FDA 510(k) clearance on 1997-03-03, under 510(k) number K970393.

Who is the listed applicant for THYROID STIMULATING HORMONE METHOD?

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

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

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

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Other records listing Dade Chemistry 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.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973099PROSTATE SPECIFIC ANTIGEN CONTROLK973101PROSTATE SPECIFIC ANTIGEN METHODK971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK970387HUMAN CHORIONIC GONADOTROPIN METHOD

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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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