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FDA 510(k)

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT

K-Number: K844167 · 1984-11-27

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1984-11-27
Product CodeDKP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY 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 1984-11-27 under 510(k) number K844167. The device is classified under product code DKP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT?

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K844167.

When did ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844167.

Who is the listed applicant for ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY 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 ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT?

The FDA product code for ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT is DKP.

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Related Devices (Code: DKP)

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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