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FDA 510(k)

SRI TSH IMMUNENZYMETRIC ASSAY

K-Number: K910837 · 1991-05-24

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-05-24
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI TSH IMMUNENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-05-24 under 510(k) number K910837. 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 SRI TSH IMMUNENZYMETRIC ASSAY?

SRI TSH IMMUNENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1991-05-24. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K910837.

When did SRI TSH IMMUNENZYMETRIC ASSAY receive FDA 510(k) clearance?

SRI TSH IMMUNENZYMETRIC ASSAY received FDA 510(k) clearance on 1991-05-24, under 510(k) number K910837.

Who is the listed applicant for SRI TSH IMMUNENZYMETRIC ASSAY?

The FDA 510(k) record lists Serono-Baker Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRI TSH IMMUNENZYMETRIC ASSAY?

The FDA product code for SRI TSH IMMUNENZYMETRIC ASSAY is JLW.

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Other records listing Serono-Baker Diagnostics, Inc. as applicant

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K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

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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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