Panels › Clinical Chemistry › Product code CIJ · Class 2
Saccharogenic, Amylase
Regulation 862.1070
0510(k)s in 12 months (31 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in CIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Harleco | 4 | 0 |
| Behring Diagnostics, Inc. | 2 | 0 |
| Biotrol, USA, Inc. | 2 | 0 |
| Coulter Electronics, Inc. | 2 | 0 |
| Data Medical Associates, Inc. | 2 | 0 |
| Em Diagnostic Systems, Inc. | 2 | 0 |
| Pointe Scientific, Inc., | 2 | 0 |
| Randox Laboratories, Ltd. | 1 | 1 |
| Ac Biochemicals, Inc. | 1 | 0 |
| American Dade | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2002 | K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) Pointe Scientific, Inc., | CIJ |
| Jul 22, 1999 | K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. | CIJ |
| Feb 4, 1998 | K980013 | AMYLASE Ac Biochemicals, Inc. | CIJ |
| Jun 21, 1996 | K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT Randox Laboratories, Ltd., IE | CIJ |
| Dec 11, 1995 | K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) Emd Chemicals, Inc. | CIJ |
| Aug 1, 1994 | K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET Pointe Scientific, Inc., | CIJ |
| Mar 11, 1994 | K940010 | DMA AMYLASE (DEMAND) PROCEDURE Data Medical Associates, Inc. | CIJ |
| Oct 18, 1993 | K931301 | OLYMPUS AMYLASE REAGENT Olympus Corp. | CIJ |
| May 26, 1993 | K931141 | BIOTROL AMYLASE CNPG3 Biotrol, USA, Inc. | CIJ |
| Jan 3, 1989 | K882225 | -AMYLASE EPS Boehringer Mannheim Corp. | CIJ |
| Oct 20, 1987 | K873572 | IL 35260, IL TEST AMYLASE REAGENT Instrumentation Laboratory CO | CIJ |
| Oct 20, 1987 | K873250 | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL Roche Diagnostic Systems, Inc. | CIJ |
| Sep 4, 1987 | K872831 | BIOTROL ALPHA AMYLASE Biotrol, USA, Inc. | CIJ |
| Jun 3, 1987 | K871943 | D.A.T. (TM) AMYLASE REAGENT Behring Diagnostics, Inc. | CIJ |
| Jan 21, 1987 | K864356 | AMYLASE REAGENT Trace Scientific , Ltd., AU | CIJ |
| Nov 13, 1986 | K863719 | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 Technicon Instruments Corp. | CIJ |
| Aug 1, 1986 | K862370 | DART AMYLASE-D.S. REAGENT SYSTEM Coulter Electronics, Inc. | CIJ |
| Jul 1, 1986 | K861664 | AMYLASE PROCEDURE Data Medical Associates, Inc. | CIJ |
| May 23, 1986 | K860935 | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 Em Diagnostic Systems, Inc. | CIJ |
| Jan 7, 1986 | K853951 | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME Behring Diagnostics, Inc. | CIJ |
| Jul 12, 1985 | K852636 | X-AMYLASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa), CA | CIJ |
| Sep 28, 1984 | K843645 | SYSTEMATE A AMYLASE HEM 67204 Em Diagnostic Systems, Inc. | CIJ |
| Feb 4, 1984 | K834053 | DART ALPHA-AMYLASE REAGENT SYSTEM Coulter Electronics, Inc. | CIJ |
| Dec 31, 1981 | K813529 | DADE COLORIMETRIC AMYLASE American Dade | CIJ |
| Oct 2, 1981 | K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 Harleco | CIJ |
| Dec 27, 1979 | K792479 | CHEM-STRATE AMYLASE General Diagnostics | CIJ |
| May 1, 1979 | K790474 | SZAMYL 6.5 Worthington Diagnostic Systems | CIJ |
| May 19, 1978 | K780513 | ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 Harleco | CIJ |
| Mar 9, 1978 | K780141 | ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. Harleco | CIJ |
| Nov 5, 1976 | K760415 | ENZYMATIC AMYLASE REAGENT KIT Beckman Instruments, Inc. | CIJ |
| Sep 21, 1976 | K760026 | ULTRAZYME AMYLASE Harleco | CIJ |
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