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FDA 510(k)

PHASE II TSH KIT

K-Number: K832499 · 1983-09-12

ApplicantMedical & Scientific Designs, Inc.
Decision Date1983-09-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHASE II TSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832499. 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 PHASE II TSH KIT?

PHASE II TSH KIT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K832499.

When did PHASE II TSH KIT receive FDA 510(k) clearance?

PHASE II TSH KIT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832499.

Who is the listed applicant for PHASE II TSH KIT?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II TSH KIT?

The FDA product code for PHASE II TSH KIT is JLW.

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Other records listing Medical & Scientific Designs, 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.

K862960PHASE II FERRITIN RADIOIMMUNOASSAY KITK853224PHASE II B-12/FOLATE KITK840901PHASE II FREE T4 KITK840328PHASE II HCG KITK834219PHASE II CORTISOL KITK833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

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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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