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FDA 510(k)

PROTEIN C CONTROL PLASMA

K-Number: K861216 · 1986-05-16

ApplicantAmerican Bioproducts Co.
Decision Date1986-05-16
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTEIN C CONTROL PLASMA 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 1986-05-16 under 510(k) number K861216. 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 PROTEIN C CONTROL PLASMA?

PROTEIN C CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is American Bioproducts Co.. The 510(k) number is K861216.

When did PROTEIN C CONTROL PLASMA receive FDA 510(k) clearance?

PROTEIN C CONTROL PLASMA received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861216.

Who is the listed applicant for PROTEIN C CONTROL PLASMA?

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 PROTEIN C CONTROL PLASMA?

The FDA product code for PROTEIN C CONTROL PLASMA is 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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