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FDA 510(k)

ORTHO TSH RIA KIT

K-Number: K791301 · 1979-09-24

ApplicantOrtho Diagnostics, Inc.
Decision Date1979-09-24
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORTHO TSH RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791301. 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 ORTHO TSH RIA KIT?

ORTHO TSH RIA KIT is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K791301.

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

ORTHO TSH RIA KIT received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791301.

Who is the listed applicant for ORTHO TSH RIA KIT?

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

What is the FDA product code for ORTHO TSH RIA KIT?

The FDA product code for ORTHO TSH RIA KIT is JLW.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK790813MULTECON BLOOD GAS CONTROL

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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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