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FDA 510(k)

ASSERA PLATE IX:AG KIT

K-Number: K854014 · 1986-01-03

ApplicantAmerican Bioproducts Co.
Decision Date1986-01-03
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASSERA PLATE IX:AG KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K854014. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSERA PLATE IX:AG KIT?

ASSERA PLATE IX:AG KIT is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is American Bioproducts Co.. The 510(k) number is K854014.

When did ASSERA PLATE IX:AG KIT receive FDA 510(k) clearance?

ASSERA PLATE IX:AG KIT received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854014.

Who is the listed applicant for ASSERA PLATE IX:AG KIT?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSERA PLATE IX:AG KIT?

The FDA product code for ASSERA PLATE IX:AG KIT is GGP.

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Related Devices (Code: GGP)

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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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