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FDA 510(k)

TSH RADIOIMMUNOASSAY

K-Number: K770892 · 1977-06-14

ApplicantKallestad Laboratories, Inc.
Decision Date1977-06-14
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-06-14 under 510(k) number K770892. 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 RADIOIMMUNOASSAY?

TSH RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770892.

When did TSH RADIOIMMUNOASSAY receive FDA 510(k) clearance?

TSH RADIOIMMUNOASSAY received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770892.

Who is the listed applicant for TSH RADIOIMMUNOASSAY?

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

What is the FDA product code for TSH RADIOIMMUNOASSAY?

The FDA product code for TSH RADIOIMMUNOASSAY is JLW.

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Other records listing Kallestad Laboratories, 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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