FDA Product Code
FDA Product Code CIJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1070
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | 2002-12-23 | Traditional | PDF ↗ |
| K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-07-22 | Traditional | PDF ↗ |
| K980013 | AMYLASE | Ac Biochemicals, Inc. | 1998-02-04 | Traditional | PDF ↗ |
| K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT | Randox Laboratories, Ltd. | 1996-06-21 | Traditional | PDF ↗ |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | 1994-08-01 | Traditional | PDF ↗ |
| K940010 | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K931301 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1993-10-18 | Traditional | PDF ↗ |
| K931141 | BIOTROL AMYLASE CNPG3 | Biotrol, USA, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K882225 | -AMYLASE EPS | Boehringer Mannheim Corp. | 1989-01-03 | Traditional | PDF ↗ |
| K873572 | IL 35260, IL TEST AMYLASE REAGENT | Instrumentation Laboratory CO | 1987-10-20 | Traditional | PDF ↗ |
| K873250 | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | Roche Diagnostic Systems, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K872831 | BIOTROL ALPHA AMYLASE | Biotrol, USA, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K871943 | D.A.T. (TM) AMYLASE REAGENT | Behring Diagnostics, Inc. | 1987-06-03 | Traditional | PDF ↗ |
| K864356 | AMYLASE REAGENT | Trace Scientific , Ltd. | 1987-01-21 | Traditional | PDF ↗ |
| K863719 | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | Technicon Instruments Corp. | 1986-11-13 | Traditional | PDF ↗ |
| K862370 | DART AMYLASE-D.S. REAGENT SYSTEM | Coulter Electronics, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K861664 | AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K860935 | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 | Em Diagnostic Systems, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K853951 | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME | Behring Diagnostics, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K852636 | X-AMYLASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | Traditional | PDF ↗ |
| K843645 | SYSTEMATE A AMYLASE HEM 67204 | Em Diagnostic Systems, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K834053 | DART ALPHA-AMYLASE REAGENT SYSTEM | Coulter Electronics, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K813529 | DADE COLORIMETRIC AMYLASE | American Dade | 1981-12-31 | Traditional | PDF ↗ |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | Harleco | 1981-10-02 | Traditional | PDF ↗ |
| K792479 | CHEM-STRATE AMYLASE | General Diagnostics | 1979-12-27 | Traditional | PDF ↗ |
| K790474 | SZAMYL 6.5 | Worthington Diagnostic Systems | 1979-05-01 | Traditional | PDF ↗ |
| K780513 | ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 | Harleco | 1978-05-19 | Traditional | PDF ↗ |
| K780141 | ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. | Harleco | 1978-03-09 | Traditional | PDF ↗ |
| K760415 | ENZYMATIC AMYLASE REAGENT KIT | Beckman Instruments, Inc. | 1976-11-05 | Traditional | PDF ↗ |
| K760026 | ULTRAZYME AMYLASE | Harleco | 1976-09-21 | Traditional | PDF ↗ |
Product code CIJ · Class II · Clinical Chemistry. Data: openFDA.