Platelin(R) Excel L

FDA 510(k) K881999 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK881999

Submission

Device name
Platelin(R) Excel L
Applicant
Organon Teknika Corp.
Durham, NC, US
Received
May 12, 1988
Decision date
August 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GIT – Reagent & Control, Partial Thromboplastin Time
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Specialty
Hematology

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K820450ThromboscreenGIT · Traditional Pacific Hemostasis03/26/1982SE

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Questions and answers

When was Platelin(R) Excel L cleared by the FDA?

Platelin(R) Excel L (K881999) received a 510(k) decision of Substantially Equivalent on August 17, 1988, 97 days after the submission was received.

What is the product code of K881999?

The FDA product code is GIT – Reagent & Control, Partial Thromboplastin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7925.