Serum Lipase Reagent Set (Turbidimetric)

FDA 510(k) K860554 · Sterling Diagnostics, Inc.

Substantially Equivalent

510(k) numberK860554

Submission

Device name
Serum Lipase Reagent Set (Turbidimetric)
Applicant
Sterling Diagnostics, Inc.
Sterling Heights, MI, US
Received
February 14, 1986
Decision date
March 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFG – Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Device class
Class I (low risk)
Regulation
21 CFR 862.1465
Specialty
Clinical Chemistry

Other 510(k)s with product code CFG

510(k)DeviceApplicantDecision
K800550Lipase DeterminationCFG · Traditional The Dow Chemical Co.04/02/1980SE

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K862210Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional 07/01/1986SE
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Questions and answers

When was Serum Lipase Reagent Set (Turbidimetric) cleared by the FDA?

Serum Lipase Reagent Set (Turbidimetric) (K860554) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 28 days after the submission was received.

What is the product code of K860554?

The FDA product code is CFG – Oil Emulsion/Thymolphthalein (Titrimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.