FDA 510(k)

HCG MAB SOLID PHASE COMPONENT SYSTEM

K-Number: K871700 · 1987-07-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1987-07-15

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HCG MAB SOLID PHASE COMPONENT SYSTEM 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 1987-07-15 under 510(k) number K871700. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCG MAB SOLID PHASE COMPONENT SYSTEM?

HCG MAB SOLID PHASE COMPONENT SYSTEM is a medical device that received FDA 510(k) clearance on 1987-07-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K871700.

When did HCG MAB SOLID PHASE COMPONENT SYSTEM receive FDA 510(k) clearance?

HCG MAB SOLID PHASE COMPONENT SYSTEM received FDA 510(k) clearance on 1987-07-15, under 510(k) number K871700.

Who is the listed applicant for HCG MAB SOLID PHASE COMPONENT SYSTEM?

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 HCG MAB SOLID PHASE COMPONENT SYSTEM?

The FDA product code for HCG MAB SOLID PHASE COMPONENT SYSTEM is JHI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.