Saccharogenic, Amylase

FDA product code CIJ · 31 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1070
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-09-21 – 2002-12-23

CIJ 2002-12-23

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)

Applicant Pointe Scientific, Inc.,

K number K023396

View details →

CIJ 1999-07-22

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K991817

View details →

CIJ 1998-02-04

AMYLASE

Applicant Ac Biochemicals, Inc.

K number K980013

View details →

CIJ 1996-06-21

AMYLASE (ETHYLIDENE PNGPG7) KIT

Applicant Randox Laboratories, Ltd.

K number K953211

View details →

CIJ 1995-12-11

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

Applicant Emd Chemicals, Inc.

K number K951494

View details →

CIJ 1994-08-01

LIQUID AMYLASE (CNPG3) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K940735

View details →

CIJ 1994-03-11

DMA AMYLASE (DEMAND) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K940010

View details →

CIJ 1993-10-18

OLYMPUS AMYLASE REAGENT

Applicant Olympus Corp.

K number K931301

View details →

CIJ 1993-05-26

BIOTROL AMYLASE CNPG3

Applicant Biotrol, USA, Inc.

K number K931141

View details →

CIJ 1989-01-03

-AMYLASE EPS

Applicant Boehringer Mannheim Corp.

K number K882225

View details →

CIJ 1987-10-20

IL 35260, IL TEST AMYLASE REAGENT

Applicant Instrumentation Laboratory CO

K number K873572

View details →

CIJ 1987-10-20

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

Applicant Roche Diagnostic Systems, Inc.

K number K873250

View details →

CIJ 1987-09-04

BIOTROL ALPHA AMYLASE

Applicant Biotrol, USA, Inc.

K number K872831

View details →

CIJ 1987-06-03

D.A.T. (TM) AMYLASE REAGENT

Applicant Behring Diagnostics, Inc.

K number K871943

View details →

CIJ 1987-01-21

AMYLASE REAGENT

Applicant Trace Scientific , Ltd.

K number K864356

View details →

CIJ 1986-11-13

AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1

Applicant Technicon Instruments Corp.

K number K863719

View details →

CIJ 1986-08-01

DART AMYLASE-D.S. REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K862370

View details →

CIJ 1986-07-01

AMYLASE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861664

View details →

CIJ 1986-05-23

EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95

Applicant Em Diagnostic Systems, Inc.

K number K860935

View details →

CIJ 1986-01-07

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

Applicant Behring Diagnostics, Inc.

K number K853951

View details →

CIJ 1985-07-12

X-AMYLASE ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K852636

View details →

CIJ 1984-09-28

SYSTEMATE A AMYLASE HEM 67204

Applicant Em Diagnostic Systems, Inc.

K number K843645

View details →

CIJ 1984-02-04

DART ALPHA-AMYLASE REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K834053

View details →

CIJ 1981-12-31

DADE COLORIMETRIC AMYLASE

Applicant American Dade

K number K813529

View details →

CIJ 1981-10-02

ULTRA ZYME PLUS AMYL #64982 & 65031

Applicant Harleco

K number K812594

View details →

CIJ 1979-12-27

CHEM-STRATE AMYLASE

Applicant General Diagnostics

K number K792479

View details →

CIJ 1979-05-01

SZAMYL 6.5

Applicant Worthington Diagnostic Systems

K number K790474

View details →

CIJ 1978-05-19

ULTRA ZYME PLUS AMYL 64982, GILFORD 3500

Applicant Harleco

K number K780513

View details →

CIJ 1978-03-09

ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.

Applicant Harleco

K number K780141

View details →

CIJ 1976-11-05

ENZYMATIC AMYLASE REAGENT KIT

Applicant Beckman Instruments, Inc.

K number K760415

View details →

CIJ 1976-09-21

ULTRAZYME AMYLASE

Applicant Harleco

K number K760026

View details →