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FDA 510(k)

IMMUNOSTAT TSH TEST

K-Number: K792562 · 1980-01-16

ApplicantMeloy Laboratories, Inc.
Decision Date1980-01-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOSTAT TSH TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meloy Laboratories, Inc.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792562. 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 IMMUNOSTAT TSH TEST?

IMMUNOSTAT TSH TEST is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K792562.

When did IMMUNOSTAT TSH TEST receive FDA 510(k) clearance?

IMMUNOSTAT TSH TEST received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792562.

Who is the listed applicant for IMMUNOSTAT TSH TEST?

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

What is the FDA product code for IMMUNOSTAT TSH TEST?

The FDA product code for IMMUNOSTAT TSH TEST is JLW.

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Other records listing Meloy Laboratories, 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.

K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAYK844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CULK841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIK842247MELOY AUTOANTIBODY TEST SYSK831292ANTI-ENA TESTK820265ANA TEST (MOUSE LIVER SUBSTRATE)

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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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