FDA 510(k)

NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY

K-Number: K912324 · 1991-06-20

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1991-06-20

Product CodeJLW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1991-06-20 under 510(k) number K912324. 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 NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY?

NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K912324.

When did NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY receive FDA 510(k) clearance?

NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY received FDA 510(k) clearance on 1991-06-20, under 510(k) number K912324.

Who is the listed applicant for NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY?

The FDA product code for NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY is JLW.

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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.