Alkaline Phosphatase, Leukocyte, Kit

FDA 510(k) K896092 · Sigma Chemical Co.

Substantially Equivalent

510(k) numberK896092

Submission

Device name
Alkaline Phosphatase, Leukocyte, Kit
Applicant
Sigma Chemical Co.
St. Louis, MO, US
Received
October 19, 1989
Decision date
November 9, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GHD – Test, Leukocyte Alkaline Phosphatase
Device class
Class I (low risk)
Regulation
21 CFR 864.7660
Specialty
Hematology

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K811189Chemstrip LGHD · Traditional Biodynamics Corp.07/27/1981SE

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Questions and answers

When was Alkaline Phosphatase, Leukocyte, Kit cleared by the FDA?

Alkaline Phosphatase, Leukocyte, Kit (K896092) received a 510(k) decision of Substantially Equivalent on November 9, 1989, 21 days after the submission was received.

What is the product code of K896092?

The FDA product code is GHD – Test, Leukocyte Alkaline Phosphatase, a Class I (low risk) device regulated under 21 CFR 864.7660.