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FDA 510(k)

DSL-4800 ACTIVE TM TSH EIA SYSTEM

K-Number: K864134 · 1986-12-16

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1986-12-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL-4800 ACTIVE TM TSH EIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K864134. 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 DSL-4800 ACTIVE TM TSH EIA SYSTEM?

DSL-4800 ACTIVE TM TSH EIA SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K864134.

When did DSL-4800 ACTIVE TM TSH EIA SYSTEM receive FDA 510(k) clearance?

DSL-4800 ACTIVE TM TSH EIA SYSTEM received FDA 510(k) clearance on 1986-12-16, under 510(k) number K864134.

Who is the listed applicant for DSL-4800 ACTIVE TM TSH EIA SYSTEM?

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

What is the FDA product code for DSL-4800 ACTIVE TM TSH EIA SYSTEM?

The FDA product code for DSL-4800 ACTIVE TM TSH EIA SYSTEM is JLW.

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Other records listing Diagnostic Systems 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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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