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FDA 510(k)

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP

K-Number: K864677 · 1987-01-07

ApplicantSerono Diagnostics, Inc.
Decision Date1987-01-07
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-01-07 under 510(k) number K864677. 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 MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP?

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP is a medical device that received FDA 510(k) clearance on 1987-01-07. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K864677.

When did TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP receive FDA 510(k) clearance?

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP received FDA 510(k) clearance on 1987-01-07, under 510(k) number K864677.

Who is the listed applicant for TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP?

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

What is the FDA product code for TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP?

The FDA product code for TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP is JLW.

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Other records listing Serono 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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