Amylase

FDA 510(k) K980013 · Ac Biochemicals, Inc.

Substantially Equivalent

510(k) numberK980013

Submission

Device name
Amylase
Applicant
Ac Biochemicals, Inc.
Irvine, CA, US
Received
January 2, 1998
Decision date
February 4, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CIJ – Saccharogenic, Amylase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1070
Specialty
Clinical Chemistry

Other 510(k)s with product code CIJ

510(k)DeviceApplicantDecision
K023396Amylase EPS-G7 (Liquid) Reagent Set, (Hitachi Analyzers)CIJ · Traditional Pointe Scientific, Inc.,12/23/2002SE
K991817Additional Ims Assays for the Bayer Advia Ims SystemCIJ · Traditional Bayer Corp.07/22/1999SE
K953211Amylase (Ethylidene PNGPG7) KitCIJ · Traditional Randox Laboratories, Ltd.06/21/1996SE
K951494Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional Emd Chemicals, Inc.12/11/1995SE
K940735Liquid Amylase (CNPG3) Reagent SetCIJ · Traditional Pointe Scientific, Inc.,08/01/1994SE
K940010Dma Amylase (Demand) ProcedureCIJ · Traditional Data Medical Associates, Inc.03/11/1994SE
K931301Olympus Amylase ReagentCIJ · Traditional Olympus Corp.10/18/1993SE
K931141Biotrol Amylase CNPG3CIJ · Traditional Biotrol, USA, Inc.05/26/1993SE
K882225-Amylase EpsCIJ · Traditional Boehringer Mannheim Corp.01/03/1989SE
K873572Il 35260, Il Test Amylase ReagentCIJ · Traditional Instrumentation Laboratory CO10/20/1987SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K982539HDLC Precipitating ReagentLBS · Traditional 09/15/1998SE
K980012Creatine Kinase ReagentJHX · Traditional 02/25/1998SE

Questions and answers

When was Amylase cleared by the FDA?

Amylase (K980013) received a 510(k) decision of Substantially Equivalent on February 4, 1998, 33 days after the submission was received.

What is the product code of K980013?

The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.