General Diagnostics Platelet Antibody

FDA 510(k) K841465 · General Diagnostics

Substantially Equivalent

510(k) numberK841465

Submission

Device name
General Diagnostics Platelet Antibody
Applicant
General Diagnostics
Walker, MI, US
Received
April 9, 1984
Decision date
July 2, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LLG – Kit, Igg, Platelet Associated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Specialty
Hematology

Other 510(k)s with product code LLG

510(k)DeviceApplicantDecision
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Questions and answers

When was General Diagnostics Platelet Antibody cleared by the FDA?

General Diagnostics Platelet Antibody (K841465) received a 510(k) decision of Substantially Equivalent on July 2, 1984, 84 days after the submission was received.

What is the product code of K841465?

The FDA product code is LLG – Kit, Igg, Platelet Associated, a Class II (moderate risk) device regulated under 21 CFR 864.5425.