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FDA 510(k)

GASTRIN EIA MODEL 06B-555017

K-Number: K961276 · 1996-05-30

ApplicantBiosyn , Ltd.
Decision Date1996-05-30
Product CodeCGC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GASTRIN EIA MODEL 06B-555017 is the device name listed in this FDA 510(k) record. The listed applicant is Biosyn , Ltd.. It received FDA 510(k) clearance on 1996-05-30 under 510(k) number K961276. 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 EIA MODEL 06B-555017?

GASTRIN EIA MODEL 06B-555017 is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is Biosyn , Ltd.. The 510(k) number is K961276.

When did GASTRIN EIA MODEL 06B-555017 receive FDA 510(k) clearance?

GASTRIN EIA MODEL 06B-555017 received FDA 510(k) clearance on 1996-05-30, under 510(k) number K961276.

Who is the listed applicant for GASTRIN EIA MODEL 06B-555017?

The FDA 510(k) record lists Biosyn , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASTRIN EIA MODEL 06B-555017?

The FDA product code for GASTRIN EIA MODEL 06B-555017 is CGC.

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Related Devices (Code: CGC)

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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.

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