Atlas FDA

CIJ

31 FDA 510(k) clearances · Product code

62 daysmedian time to decision
217 days90th percentile
31clearances measured

FDA profile

Official device name
Saccharogenic, Amylase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1070
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396)Pointe Scientific, Inc.,2002-12-23
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991817)Bayer Corp.1999-07-22
AMYLASE (K980013)Ac Biochemicals, Inc.1998-02-04
AMYLASE (ETHYLIDENE PNGPG7) KIT (K953211)Randox Laboratories, Ltd.1996-06-21
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (K951494)Emd Chemicals, Inc.1995-12-11
LIQUID AMYLASE (CNPG3) REAGENT SET (K940735)Pointe Scientific, Inc.,1994-08-01
DMA AMYLASE (DEMAND) PROCEDURE (K940010)Data Medical Associates, Inc.1994-03-11
OLYMPUS AMYLASE REAGENT (K931301)Olympus Corp.1993-10-18
BIOTROL AMYLASE CNPG3 (K931141)Biotrol, USA, Inc.1993-05-26
-AMYLASE EPS (K882225)Boehringer Mannheim Corp.1989-01-03
IL 35260, IL TEST AMYLASE REAGENT (K873572)Instrumentation Laboratory CO1987-10-20
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL (K873250)Roche Diagnostic Systems, Inc.1987-10-20
BIOTROL ALPHA AMYLASE (K872831)Biotrol, USA, Inc.1987-09-04
D.A.T. (TM) AMYLASE REAGENT (K871943)Behring Diagnostics, Inc.1987-06-03
AMYLASE REAGENT (K864356)Trace Scientific , Ltd.1987-01-21
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 (K863719)Technicon Instruments Corp.1986-11-13
DART AMYLASE-D.S. REAGENT SYSTEM (K862370)Coulter Electronics, Inc.1986-08-01
AMYLASE PROCEDURE (K861664)Data Medical Associates, Inc.1986-07-01
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 (K860935)Em Diagnostic Systems, Inc.1986-05-23
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME (K853951)Behring Diagnostics, Inc.1986-01-07
X-AMYLASE ASSAY KIT (K852636)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
SYSTEMATE A AMYLASE HEM 67204 (K843645)Em Diagnostic Systems, Inc.1984-09-28
DART ALPHA-AMYLASE REAGENT SYSTEM (K834053)Coulter Electronics, Inc.1984-02-04
DADE COLORIMETRIC AMYLASE (K813529)American Dade1981-12-31
ULTRA ZYME PLUS AMYL #64982 & 65031 (K812594)Harleco1981-10-02
CHEM-STRATE AMYLASE (K792479)General Diagnostics1979-12-27
SZAMYL 6.5 (K790474)Worthington Diagnostic Systems1979-05-01
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 (K780513)Harleco1978-05-19
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. (K780141)Harleco1978-03-09
ENZYMATIC AMYLASE REAGENT KIT (K760415)Beckman Instruments, Inc.1976-11-05
ULTRAZYME AMYLASE (K760026)Harleco1976-09-21

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