Panels › Clinical Chemistry › Product code JFJ · Class 2
Catalytic Methods, Amylase
Regulation 862.1070
0510(k)s in 12 months (99 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JFJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 1991 | K913858 | AMYLASE REAGENT (PROCEDURE 577) Sigma Diagnostics, Inc. | JFJ |
| Jul 1, 1991 | K912519 | AMYLASE REAGENT Genzyme Corp. | JFJ |
| Apr 30, 1991 | K910158 | AMYLASE Pointe Scientific, Inc., | JFJ |
| Jan 31, 1991 | K905651 | KINETIC AMYLASE DETERMINATION Biochemical Trade, Inc. | JFJ |
| Sep 7, 1990 | K903309 | ROCHE COBAS READY AMYLASE REAGENT Roche Diagnostic Systems, Inc. | JFJ |
| Aug 17, 1990 | K903332 | SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 Em Diagnostic Systems, Inc. | JFJ |
| Jul 31, 1990 | K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | JFJ |
| May 15, 1990 | K901017 | DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI E.I. Dupont DE Nemours & Co., Inc. | JFJ |
| Apr 3, 1990 | K900230 | COULTER AMYLASE REAGENT Coulter Corp. | JFJ |
| Feb 8, 1990 | K896650 | AMYLASE REAGENT Sigma Chemical Co. | JFJ |
| Aug 17, 1989 | K893751 | AMYLASE TEST (AML) ITEM NUMBER: 65404 Em Diagnostic Systems, Inc. | JFJ |
| Aug 15, 1989 | K891241 | ABBOTT SPECTRUM AMYLASE REAGENT Abbott Laboratories | JFJ |
| Jul 20, 1989 | K892848 | PANCREATIC A-AMYLASE PNP Boehringer Mannheim Corp. | JFJ |
| Feb 17, 1989 | K885176 | AMYLASE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. | JFJ |
| Apr 19, 1988 | K880867 | AMYLASE 405 CATALOG NUMBER 301-34 Diagnostic Chemicals, Ltd. (Usa) | JFJ |
| Jan 5, 1988 | K874704 | REFLOTRON (R) AMYLASE Boehringer Mannheim Corp. | JFJ |
| Nov 23, 1987 | K873944 | A-GENT LIQUID AMYLASE Abbott Laboratories | JFJ |
| Oct 6, 1987 | K873133 | BNP-AMYLASE TEST Sclavo, Inc. | JFJ |
| Aug 5, 1987 | K872023 | AMYLASE TEST KIT Ciba Corning Diagnostics Corp. | JFJ |
| Jun 1, 1987 | K870746 | STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 Stanbio Laboratory | JFJ |
| Apr 13, 1987 | K871269 | RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) Technicon Instruments Corp. | JFJ |
| Feb 20, 1987 | K864825 | AMYLASE COLORIMETRIC PROCEDURE Data Medical Associates, Inc. | JFJ |
| Jan 21, 1987 | K864464 | PSI AMYLASE REAGENT Pointe Scientific, Inc., | JFJ |
| Dec 31, 1986 | K864303 | QKO (TM) AMYLASE B-HA Wako Chemicals USA, Inc. | JFJ |
| Dec 16, 1986 | K864435 | VISION(TM) AMYLASE Abbott Laboratories | JFJ |
| Oct 3, 1986 | K863622 | TDX(R) AMYLASE II Abbott Laboratories | JFJ |
| Sep 29, 1986 | K863588 | AMYLASE PROCEDURE Data Medical Associates, Inc. | JFJ |
| Sep 29, 1986 | K862733 | AMYLASE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. | JFJ |
| May 29, 1986 | K861718 | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 Reagents Applications, Inc. | JFJ |
| May 29, 1986 | K861269 | RAICHEM AMYLASE REAGENT Reagents Applications, Inc. | JFJ |
| Apr 7, 1986 | K860665 | ALPHA-AMYLASE TEST Sclavo, Inc. | JFJ |
| Apr 3, 1986 | K860918 | EASY-TEST AMLASE (AMYL), #67521/93 Em Diagnostic Systems, Inc. | JFJ |
| Mar 14, 1986 | K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT Bio-Analytics Laboratories, Inc. | JFJ |
| Jun 10, 1985 | K852001 | AMY REAGENT Alpkem Corp. | JFJ |
| Mar 14, 1985 | K850798 | AMYLASE PRODUCTS Data Medical Associates, Inc. | JFJ |
| Nov 25, 1983 | K832889 | AMYLASE Pointe Scientific, Inc., | JFJ |
| Jul 7, 1983 | K831561 | AMYLAST-D TEST Sclavo, Inc. | JFJ |
| Jun 17, 1983 | K831536 | PARAMAX AMALINE REAGENT American Dade | JFJ |
| Dec 28, 1982 | K823462 | SINGLE VIAL AMYLASE PNP TEST Boehringer Mannheim Corp. | JFJ |
| Jul 13, 1982 | K821869 | ULTRAZYME PLUS AMYL Harleco Diagnostics | JFJ |
| May 28, 1982 | K821459 | ULTRAZYME PLUS AMYL #65031&64982 Emd Chemicals, Inc. | JFJ |
| Nov 12, 1980 | K802581 | BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY Beckman Instruments, Inc. | JFJ |
| Jul 8, 1980 | K801295 | COBAS REAGENT FOR A-AMYLASE Roche Analytical Instruments, Inc. | JFJ |
| Jan 23, 1980 | K800049 | DELTA TEST AMYLASE UV Bd Becton Dickinson Vacutainer Systems Preanalytic | JFJ |
| Nov 17, 1977 | K772035 | GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL Harleco | JFJ |
| Sep 13, 1977 | K771622 | MULTISTAT III, AMYLASE TEST Instrumentation Laboratory CO | JFJ |
| Sep 2, 1977 | K771388 | AMYLASE ULTRAZYME PLUS Harleco | JFJ |
| Jul 21, 1977 | K771131 | CLINICARD UV AMYLASE CHEMISTRY Harleco | JFJ |
| Jul 5, 1977 | K770750 | REAGENT KIT, ENZYMATIC AMYLASE Beckman Instruments, Inc. | JFJ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.