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FDA 510(k)

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

K-Number: K884485 · 1988-12-28

ApplicantKing Diagnostics, Inc.
Decision Date1988-12-28
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-12-28 under 510(k) number K884485. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT?

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K884485.

When did KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT receive FDA 510(k) clearance?

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT received FDA 510(k) clearance on 1988-12-28, under 510(k) number K884485.

Who is the listed applicant for KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT?

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

What is the FDA product code for KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT?

The FDA product code for KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT is GFO.

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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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