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FDA 510(k)

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT

K-Number: K942638 · 1994-09-07

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1994-09-07
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT 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 1994-09-07 under 510(k) number K942638. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT?

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K942638.

When did SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT receive FDA 510(k) clearance?

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT received FDA 510(k) clearance on 1994-09-07, under 510(k) number K942638.

Who is the listed applicant for SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT?

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 SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT?

The FDA product code for SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT is CEP.

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Related Devices (Code: CEP)

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.

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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.

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