Hichem Alp/Amp Reagent Kit

FDA 510(k) K963383 · Hichem Diagnostics

Substantially Equivalent

510(k) numberK963383

Submission

Device name
Hichem Alp/Amp Reagent Kit
Applicant
Hichem Diagnostics
Brea, CA, US
Received
August 27, 1996
Decision date
September 23, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CKF – Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Specialty
Clinical Chemistry

Other 510(k)s with product code CKF

510(k)DeviceApplicantDecision
K072142S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstCKF · Traditional Alfa Wassermann Diagnostic Technologies, Inc.06/26/2008SE

More from Alfa Wassermann Diagnostic Technologies, Inc.

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K981794Hichem Calcium Reagent KitCJY · Traditional 07/29/1998SE
K953863Hichem Ise Standards Kit 70011JIX · Traditional 09/06/1995SE
K953862Hichem Isekci Solution Kit 70010CGZ · Traditional 09/06/1995SE
K953861Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional 09/06/1995SE
K953860Hichem Ise Diluent Kit 70008CGZ · Traditional 09/06/1995SE
K951751Hichem Ast Reagent KitCIT · Traditional 08/02/1995SE
K946192Hichem Y-Gt Reagent KitJQB · Traditional 05/02/1995SE
K946022Hichem Ldh/L Reagent KitCFJ · Traditional 02/23/1995SE
K941433Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional 08/02/1994SE
K925612Hi Chem Electrolyte BufferJGS · Traditional 04/20/1993SE

Questions and answers

When was Hichem Alp/Amp Reagent Kit cleared by the FDA?

Hichem Alp/Amp Reagent Kit (K963383) received a 510(k) decision of Substantially Equivalent on September 23, 1996, 27 days after the submission was received.

What is the product code of K963383?

The FDA product code is CKF – Phenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.