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FDA 510(k)

SERALUTE TSH (RIA)

K-Number: K771767 · 1977-10-25

ApplicantMiles Laboratories, Inc.
Decision Date1977-10-25
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALUTE TSH (RIA) is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-10-25 under 510(k) number K771767. 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 SERALUTE TSH (RIA)?

SERALUTE TSH (RIA) is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K771767.

When did SERALUTE TSH (RIA) receive FDA 510(k) clearance?

SERALUTE TSH (RIA) received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771767.

Who is the listed applicant for SERALUTE TSH (RIA)?

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

What is the FDA product code for SERALUTE TSH (RIA)?

The FDA product code for SERALUTE TSH (RIA) 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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