FDA 510(k)

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA

K-Number: K861049 · 1986-05-29

Decision Date1986-05-29

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1986-05-29 under 510(k) number K861049. 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 HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA?

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Sigma Chemical Co.. The 510(k) number is K861049.

When did HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA receive FDA 510(k) clearance?

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861049.

Who is the listed applicant for HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA?

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

What is the FDA product code for HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA?

The FDA product code for HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA is GGP.

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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.