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FDA 510(k)

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL

K-Number: K883726 · 1988-12-15

ApplicantImmuchem Corp.
Decision Date1988-12-15
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K883726. 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 THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL?

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Immuchem Corp.. The 510(k) number is K883726.

When did THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL receive FDA 510(k) clearance?

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL received FDA 510(k) clearance on 1988-12-15, under 510(k) number K883726.

Who is the listed applicant for THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL?

The FDA 510(k) record lists Immuchem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL?

The FDA product code for THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL is JLW.

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Other records listing Immuchem Corp. 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.

K871317FOLLICLE STIMULATING HORMONE (HFSH)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIAK854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

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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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