FDA Product Code
FDA Product Code CJE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 124 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251074 | Tru Liver Health Test Panel | Truvian Health | 2025-12-19 | Traditional | PDF ↗ |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | 2024-10-16 | Special | PDF ↗ |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | 2023-07-21 | Traditional | PDF ↗ |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS | 2019-08-30 | Traditional | PDF ↗ |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | Lite-On Technology Corp. H.S.P.B. | 2018-01-25 | Traditional | PDF ↗ |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017-05-10 | Special | PDF ↗ |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories Limited | 2017-04-21 | Traditional | PDF ↗ |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 | Traditional | PDF ↗ |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | Hitachi Chemical Diagnostics, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | Alfa Wassermann | 2012-07-12 | Traditional | PDF ↗ |
| K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | Elitechgroup | 2011-12-29 | Traditional | PDF ↗ |
| K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | Medica Corp. | 2011-05-20 | Traditional | PDF ↗ |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 | Traditional | PDF ↗ |
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2006-07-21 | Traditional | PDF ↗ |
| K033185 | COBAS INTEGRA ALP IFCC GEN.2 | Roche Diagnostics Corp. | 2003-10-14 | Special | PDF ↗ |
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | 2002-12-26 | Special | PDF ↗ |
| K013983 | WIENER LAB. ALP 405 | Wiener Laboratories Saic | 2002-01-28 | Traditional | PDF ↗ |
| K012518 | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 | Thermo Dma, Inc. | 2001-10-09 | Abbreviated | PDF ↗ |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-07-20 | Traditional | PDF ↗ |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | 2000-11-27 | Traditional | PDF ↗ |
| K002285 | ATAC PAK ALP REAGENT KIT | Elan Diagnostics | 2000-09-26 | Traditional | PDF ↗ |
| K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H | Teco Diagnostics | 2000-01-20 | Special | PDF ↗ |
| K991762 | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | A.P. Total Care, Inc. | 1999-09-02 | Traditional | PDF ↗ |
| K991387 | ELAN ALKALINE PHOSPHATE REAGENT KIT | Elan Holdings, Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K990024 | CARESIDE ALKALINE PHOSPHATASE | Careside, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE | Roche Diagnostic Systems, Inc. | 1998-08-26 | Traditional | PDF ↗ |
| K981806 | ALKP | Abbott Laboratories | 1998-06-22 | Traditional | PDF ↗ |
| K981245 | ALKALINE PHOSPHATASE (ALKP) | Abbott Laboratories | 1998-05-20 | Traditional | PDF ↗ |
| K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 | Diagnostic Chemicals , Ltd. | 1998-02-12 | Traditional | PDF ↗ |
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | Pointe Scientific, Inc., | 1997-10-22 | Traditional | PDF ↗ |
| K971463 | ALP REAGENT SET | Carolina Liquid Chemistries Corp. | 1997-05-16 | Traditional | PDF ↗ |
| K964914 | ALKALINE PHOSPHATASE | Derma Media Lab., Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K954840 | ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 | Sigma Diagnostics, Inc. | 1996-02-28 | Traditional | PDF ↗ |
| K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-11-27 | Traditional | PDF ↗ |
| K951584 | ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 | Sigma Diagnostics, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | Prisma Systems | 1994-12-29 | Traditional | PDF ↗ |
| K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET | Stanbio Laboratory | 1994-05-17 | Traditional | PDF ↗ |
| K935182 | EMDS ALKANINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 | Traditional | PDF ↗ |
| K931986 | AMP ALKALINE PHOSPHATASE REAGENT KIT | Synermed, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K923507 | ALKALINE PHOSPHATASE KIT | Randox Laboratories, Ltd. | 1992-12-03 | Traditional | PDF ↗ |
| K925156 | OLYMPUS ALKALINE PHOSPHATASE REAGENT | Olympus Corp. | 1992-11-18 | Traditional | PDF ↗ |
| K924574 | EMDS ALKALINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K923527 | OLYMPUS ALKALINE PHOSPHATASE REAGENT | Olympus Corp. | 1992-09-28 | Traditional | PDF ↗ |
| K913921 | ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 | Em Diagnostic Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K910639 | SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 | Em Diagnostic Systems, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Biochemical Trade, Inc. | 1991-02-13 | Traditional | PDF ↗ |
| K905684 | ALKALINE PHOSPHATASE | Amresco, Inc. | 1990-12-28 | Traditional | PDF ↗ |
| K904030 | SYNERMED ALKALINE PHOSPHATASE REAGENT KIT | Synermed, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K902560 | ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT | Roche Diagnostic Systems, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K900250 | AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 | American Research Products Co. | 1990-03-01 | Traditional | PDF ↗ |
| K900216 | COULTER ALP (ALK PHOS) REAGENT | Coulter Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K895250 | SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 | Em Diagnostic Systems, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K890521 | ABBOTT CLINICAL CHEMISTRY REAGENT ALP | Abbott Laboratories | 1989-03-24 | Traditional | PDF ↗ |
| K884549 | ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 | Em Diagnostic Systems, Inc. | 1988-11-10 | Traditional | PDF ↗ |
| K881742 | BIOTROL ALKALINE PHOSPHATASE | Biotrol, USA, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880795 | RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. | Trace America, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880796 | ALKALINE PHOSPHATASE REAGENT, DEA BUFF | Trace America, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880307 | ALKALINE PHOSPHATASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K875210 | ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-02 | Traditional | PDF ↗ |
| K873635 | EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 | Em Diagnostic Systems, Inc. | 1987-10-29 | Traditional | PDF ↗ |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Simmler, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K873333 | WAKO(TM) AUTOKIT ALP | Wako Chemicals USA, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K873681 | ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 | Em Diagnostic Systems, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K871543 | ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. | Catachem, Inc. | 1987-06-22 | Traditional | PDF ↗ |
| K864905 | ALKALINE PHOSPHATASE | Tech-Co, Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K863980 | U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST | U. S. Diagnostics, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863268 | ALKALINE PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862498 | ALKALINE PHOSPHATASE TEST | King Diagnostics, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863051 | ALP S.C.E. | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K862905 | ALP (OPT) REAGENT | Sigma Diagnostics, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861667 | ALKALINE PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K861284 | AP REAGENT CARTRIDGE | Hi Chem, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K860715 | ALP (ALKALINE PHOSPHATASE) REAGENT | Trace Scientific , Ltd. | 1986-04-24 | Traditional | PDF ↗ |
| K860134 | EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT | Em Diagnostic Systems, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K852441 | IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN | Clinical Data, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852752 | AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE | American Research Products Co. | 1985-07-23 | Traditional | PDF ↗ |
| K852784 | ALKALINE PHOSPHATASE | Advanced Biomedical Methods, Inc. | 1985-07-22 | Traditional | PDF ↗ |
| K851998 | ALP(ALKALINE)(PHOSPHATASE) REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K850110 | VISION -FORMERLY PDA- ALKALINE PHOSPHATASE | Abbott Laboratories | 1985-01-29 | Traditional | PDF ↗ |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | Sterling Biochemical, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K843270 | SYSTEMATE ALKALINE PHOSPHATASE-67203 | Em Diagnostic Systems, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K842243 | ALKALINE PHOSPHATASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K841918 | SIGMA PROCED. 245 ALKALINE PHOSPHATASE | Sigma Diagnostics, Inc. | 1984-06-14 | Traditional | PDF ↗ |
| K834033 | KINETIC ALKALINE PHOSPHATASE | American Monitor Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K833744 | ALKALINE PHOSPHATASE-RATE | Seragen Diagnostics, Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K832463 | RAICHEM ALKALINE PHOSPHATASE REAGENT | Reagents Applications, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831480 | PARAMAX ALKALINE PHOSPHATASE REAGENT- | American Dade | 1983-06-22 | Traditional | PDF ↗ |
| K831360 | DATA-ZYME ALKALINE PHOSPHATASE PROCED | Data Medical Associates, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K823786 | ALKALINE PHOSPHATASE | Analytical & Research Chemicals, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823213 | DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI | Boehringer Mannheim Corp. | 1982-11-22 | Traditional | PDF ↗ |
| K821870 | ULTRAZYME PLUS ALP | Harleco Diagnostics | 1982-07-13 | Traditional | PDF ↗ |
| K821471 | ULTRAZYME PLUS ALP #64962,65029&65030 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K812912 | GILCHEM ALP REAGENT | Gilford Diagnostics | 1981-11-02 | Traditional | PDF ↗ |
| K812596 | ULTRA ZYME PLUS ALP #64962, 65029 & 30 | Harleco | 1981-09-29 | Traditional | PDF ↗ |
| K812452 | ALKALINE PHOSPHATASE | Pointe Scientific, Inc., | 1981-09-09 | Traditional | PDF ↗ |
| K810082 | ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT | Bio-Analytics Laboratories, Inc. | 1981-01-26 | Traditional | PDF ↗ |
| K802574 | BECKMAN LIQUID STAT LIQUID/ALKALINE PHO | Beckman Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801242 | COBAS REAGENT FOR ALKALINE PHOSPHATASE | Roche Analytical Instruments, Inc. | 1980-06-20 | Traditional | PDF ↗ |
Product code CJE · Class II · Clinical Chemistry. Data: openFDA.