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FDA 510(k)

EPSILON TSH TEST KIT

K-Number: K831972 · 1983-09-20

ApplicantBeckman Instruments, Inc.
Decision Date1983-09-20
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EPSILON TSH TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K831972. 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 EPSILON TSH TEST KIT?

EPSILON TSH TEST KIT is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K831972.

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

EPSILON TSH TEST KIT received FDA 510(k) clearance on 1983-09-20, under 510(k) number K831972.

Who is the listed applicant for EPSILON TSH TEST KIT?

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

What is the FDA product code for EPSILON TSH TEST KIT?

The FDA product code for EPSILON TSH TEST KIT is JLW.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JLW)

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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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