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FDA 510(k)

GASTRIN RADIOIMMUNOASSAY KIT (125-I)

K-Number: K821175 · 1982-05-14

Decision Date1982-05-14
Product CodeCGC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GASTRIN RADIOIMMUNOASSAY KIT (125-I) 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 1982-05-14 under 510(k) number K821175. The device is classified under product code CGC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTRIN RADIOIMMUNOASSAY KIT (125-I)?

GASTRIN RADIOIMMUNOASSAY KIT (125-I) is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821175.

When did GASTRIN RADIOIMMUNOASSAY KIT (125-I) receive FDA 510(k) clearance?

GASTRIN RADIOIMMUNOASSAY KIT (125-I) received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821175.

Who is the listed applicant for GASTRIN RADIOIMMUNOASSAY KIT (125-I)?

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 GASTRIN RADIOIMMUNOASSAY KIT (125-I)?

The FDA product code for GASTRIN RADIOIMMUNOASSAY KIT (125-I) is CGC.

Related Clinical Trials

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.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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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Related Devices (Code: CGC)

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.

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.

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