Product code CIJ
- Device name
- Saccharogenic, Amylase
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1070
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | 2002-12-23 |
| K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-07-22 |
| K980013 | AMYLASE | Ac Biochemicals, Inc. | 1998-02-04 |
| K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT | Randox Laboratories, Ltd. | 1996-06-21 |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | 1995-12-11 |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | 1994-08-01 |
| K940010 | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | 1994-03-11 |
| K931301 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1993-10-18 |
| K931141 | BIOTROL AMYLASE CNPG3 | Biotrol, USA, Inc. | 1993-05-26 |
| K882225 | -AMYLASE EPS | Boehringer Mannheim Corp. | 1989-01-03 |
| K873572 | IL 35260, IL TEST AMYLASE REAGENT | Instrumentation Laboratory CO | 1987-10-20 |
| K873250 | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | Roche Diagnostic Systems, Inc. | 1987-10-20 |
| K872831 | BIOTROL ALPHA AMYLASE | Biotrol, USA, Inc. | 1987-09-04 |
| K871943 | D.A.T. (TM) AMYLASE REAGENT | Behring Diagnostics, Inc. | 1987-06-03 |
| K864356 | AMYLASE REAGENT | Trace Scientific , Ltd. | 1987-01-21 |
| K863719 | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | Technicon Instruments Corp. | 1986-11-13 |
| K862370 | DART AMYLASE-D.S. REAGENT SYSTEM | Coulter Electronics, Inc. | 1986-08-01 |
| K861664 | AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 |
| K860935 | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 | Em Diagnostic Systems, Inc. | 1986-05-23 |
| K853951 | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME | Behring Diagnostics, Inc. | 1986-01-07 |
| K852636 | X-AMYLASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 |
| K843645 | SYSTEMATE A AMYLASE HEM 67204 | Em Diagnostic Systems, Inc. | 1984-09-28 |
| K834053 | DART ALPHA-AMYLASE REAGENT SYSTEM | Coulter Electronics, Inc. | 1984-02-04 |
| K813529 | DADE COLORIMETRIC AMYLASE | American Dade | 1981-12-31 |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | Harleco | 1981-10-02 |
| K792479 | CHEM-STRATE AMYLASE | General Diagnostics | 1979-12-27 |
| K790474 | SZAMYL 6.5 | Worthington Diagnostic Systems | 1979-05-01 |
| K780513 | ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 | Harleco | 1978-05-19 |
| K780141 | ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. | Harleco | 1978-03-09 |
| K760415 | ENZYMATIC AMYLASE REAGENT KIT | Beckman Instruments, Inc. | 1976-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811727016034 | Pointe Amylase Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00811727015723 | Pointe Amylase on BS480 Analyzer | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 00852169008041 | ClearChem Diagnostics Inc. Amylase | CLEARCHEM DIAGNOSTICS INC. | 2018-04-30 |
| 00817439020215 | Amylase / BS200 | Medtest Dx, Inc. | 2016-09-27 |
| 00817439020192 | Amylase / BS480 | Medtest Dx, Inc. | 2016-09-27 |
| 00857969006228 | ACE | ALFA WASSERMANN, INC. | 2016-09-24 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| 00015482771133 | SPOTCHEM™ II Amylase | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771157 | SPOTCHEM™ II ALP | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771164 | SPOTCHEM™ II Creatinine | ARKRAY USA, INC. | 2016-09-23 |
| EABA40000031 | Piccolo Liver Panel Plus | ABAXIS, INC. | 2016-09-23 |
| 05055273200676 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200652 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200645 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200607 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200584 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200577 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200560 | AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 00811727010285 | POINTE SCIENTIFIC Amylase | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010292 | POINTE SCIENTIFIC Amylase | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010308 | POINTE SCIENTIFIC AMYLASE | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010315 | POINTE SCIENTIFIC AMYLASE | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727012562 | Pointe Scientfic, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727012906 | Pointe Scientific | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727013422 | POINTE SCIENTIFIC Amylase | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727013835 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727014641 | Pointe Scientific, Inc. Amylase | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727014931 | Pointe Scientific, Inc. Amylase | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |