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FDA 510(k)

PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE

K-Number: K844171 · 1984-12-10

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1984-12-10
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE 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 1984-12-10 under 510(k) number K844171. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE?

PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE is a medical device that received FDA 510(k) clearance on 1984-12-10. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K844171.

When did PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE receive FDA 510(k) clearance?

PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE received FDA 510(k) clearance on 1984-12-10, under 510(k) number K844171.

Who is the listed applicant for PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE?

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 PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE?

The FDA product code for PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE is LGR.

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Related Devices (Code: LGR)

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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