FDA Product Code
FDA Product Code JJE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2160
510(k) Clearances — 208 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K882081 | SPECIFIC CHEMISTRY ANALYZER | The Rupp & Bowman Co. | 1988-07-01 | Traditional | PDF ↗ |
| K881498 | SYNCHRON CX(TM)4 CLINICAL ANALYZER | Beckman Instruments, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K881495 | SYNCHRON CX(TM)5 CLINICAL ANALYZER | Beckman Instruments, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K874857 | KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0 | Eastman Kodak Company | 1988-02-08 | Traditional | PDF ↗ |
| K873130 | WASH SOLUTION KIT | A-Kem, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K873617 | GEMSTAR II SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1987-10-19 | Traditional | PDF ↗ |
| K873749 | CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER | Ciba Corning Diagnostics Corp. | 1987-10-19 | Traditional | PDF ↗ |
| K872302 | MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1987-09-08 | Traditional | PDF ↗ |
| K864849 | ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER | Antek Instruments, Inc. | 1987-08-28 | Traditional | PDF ↗ |
| K872813 | EASY ST ANALYZER SYSTEM | Em Diagnostic Systems, Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K872494 | HITACHI 717 CHEMISTRY ANALYZER | Boehringer Mannheim Corp. | 1987-07-09 | Traditional | PDF ↗ |
| K872105 | KODAK EKTACHEM 700XR ANALYZER | Eastman Kodak Company | 1987-06-23 | Traditional | PDF ↗ |
| K872104 | KODAK EKTACHEM 700P ANALYZER | Eastman Kodak Company | 1987-06-17 | Traditional | PDF ↗ |
| K872103 | KODAK EKTACHEM 700S ANALYZER | Eastman Kodak Company | 1987-06-17 | Traditional | PDF ↗ |
| K870833 | CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY | Ciba Corning Diagnostics Corp. | 1987-04-01 | Traditional | PDF ↗ |
| K870836 | ATAC 1500 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K865105 | AFFINITY(TM) SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-12 | Traditional | PDF ↗ |
| K863840 | METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K863531 | IQ IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-20 | Traditional | PDF ↗ |
| K862235 | CIBA CORNING MAGIC LITE ANALYZER | Ciba Corning Diagnostics Corp. | 1986-09-08 | Traditional | PDF ↗ |
| K862818 | STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1986-08-19 | Traditional | PDF ↗ |
| K861055 | EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 | Em Diagnostic Systems, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860748 | HITACHI 736 | Boehringer Mannheim Corp. | 1986-04-17 | Traditional | PDF ↗ |
| K860647 | ES600 IMMUNOASSAY SYSTEM | Boehringer Mannheim Corp. | 1986-04-17 | Traditional | PDF ↗ |
| K860021 | DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K854936 | EIA PROCESSOR | Abbott Laboratories | 1986-02-06 | Traditional | PDF ↗ |
| K860080 | OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM | Olympus Corp. | 1986-01-24 | Traditional | PDF ↗ |
| K855196 | CLEANING REAGENT KIT PRODUCT NO 88194 | Hi Chem, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K853621 | REPLACEMENT PUMP TUBING | Shaban Mfg. Co. | 1985-12-05 | Traditional | PDF ↗ |
| K854243 | ES 22 | Boehringer Mannheim Corp. | 1985-11-19 | Traditional | PDF ↗ |
| K854138 | KODAKEKTACHEM DTR MODULE | Eastman Kodak Company | 1985-11-12 | Traditional | PDF ↗ |
| K854025 | HITACHI 704 | Boehringer Mannheim Corp. | 1985-10-28 | Traditional | PDF ↗ |
| K853391 | MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 | Eiken Chemical Co., Inc. | 1985-10-01 | Traditional | PDF ↗ |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | Diagnostic Systems | 1985-09-25 | Traditional | PDF ↗ |
| K852133 | REFLOTRON SYSTEM | Boehringer Mannheim Corp. | 1985-09-16 | Traditional | PDF ↗ |
| K853003 | HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 | Hi Chem, Inc. | 1985-08-06 | Traditional | PDF ↗ |
| K852262 | ASSIST CLINICAL CHEMISTRY ANALYZER | Cooper Biomedical, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K851638 | CLINALYZER MODEL VX-1000 | Alpkem Corp. | 1985-05-13 | Traditional | PDF ↗ |
| K844114 | ADD-1 | Abbott Laboratories | 1984-11-27 | Traditional | PDF ↗ |
| K843082 | ANALOX LM3 MICRO-STAT ANALYSER | Analox Instruments , Ltd. | 1984-10-17 | Traditional | PDF ↗ |
| K843059 | ATAC 2000 | Turpen Laboratory Systems, Inc. | 1984-10-11 | Traditional | PDF ↗ |
| K843610 | PERSPECTIVE CHEMICAL ANALYZER | American Monitor Corp. | 1984-10-05 | Traditional | PDF ↗ |
| K843283 | BOEHRINGER MANNHEIM DIAGNOSTICS ADAM | Boehringer Mannheim Corp. | 1984-10-05 | Traditional | PDF ↗ |
| K842773 | LABSYSTEMS FP-901 CHEMISTRY ANALYZER | Labsystems, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K842500 | DATA MGMT. SYSTEM | Gilford | 1984-08-16 | Traditional | PDF ↗ |
| K841916 | ABBOTT PROJECT I | Abbott Laboratories | 1984-06-22 | Traditional | PDF ↗ |
| K840868 | AMRESCO E4A REAGENT SET | American Research Products Co. | 1984-05-22 | Traditional | PDF ↗ |
| K841503 | KODAK EKTACHEM DT 60 ANALYZER | Eastman Kodak Company | 1984-05-22 | Traditional | PDF ↗ |
| K840883 | UNIPAK 100 ANALYZER, 65156 & CHEMISTR | Emd Chemicals, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K841076 | ION SELECTIVE ELECTRODE | Cooper Biomedical, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K840501 | ACCULAB SUPPLIES CHEMICAL ANALYZERS | Precision Technology, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K840129 | UNI-FAST ANALYZER SYSTEM | Sclavo, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K840120 | ADVANTAGE | Gilford | 1984-03-23 | Traditional | PDF ↗ |
| K834534 | APSARA ANALYZER | Datachem, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K834521 | DISCRETE CLINICAL ANALYZER | E.I. Dupont DE Nemours & Co., Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K833833 | KODAK EKTACHEM 700 ANALYZER | Eastman Kodak Company | 1984-01-17 | Traditional | PDF ↗ |
| K832115 | ATAC 3000 | Turpen Laboratory Systems, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K833448 | EPOS CHEMISTRY ANALYZER 5060 & 6410 | Emd Chemicals, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K833067 | IMPACT 400 #1447X2 | Gilford | 1983-12-08 | Traditional | PDF ↗ |
| K833116 | SPIRIT CHEMISTRY SYSTEM | Baker Instructions Corp. | 1983-11-07 | Traditional | PDF ↗ |
| K832648 | ACCLAIM | Electro-Nucleonics Laboratories, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K832584 | TUBING KIT 446 | Shaban Mfg. Co. | 1983-09-12 | Traditional | PDF ↗ |
| K831649 | THERMOMIXER S213-PHOTOANALYZER S263 | Texas Intl. Laboratories, Inc. | 1983-08-24 | Traditional | PDF ↗ |
| K831518 | AUTO CAROUSE/WASH SOLUTION CONCENTRATE | Syva Co. | 1983-06-22 | Traditional | PDF ↗ |
| K831477 | DEMAND ANALYZER SYSTEM | Worthington Diagnostic Systems | 1983-06-17 | Traditional | PDF ↗ |
| K830762 | OLYMPUS HIGH SPEED ANALYZER | Olympus Corp. | 1983-04-12 | Traditional | PDF ↗ |
| K830212 | ELISA PLUS SYSTEM | William-Palmer Industries, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K830318 | PARAMAX ANALYTICAL SYS | American Dade | 1983-03-07 | Traditional | PDF ↗ |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | American Hospital Supply Corp. | 1983-02-25 | Traditional | PDF ↗ |
| K823386 | APSARA CLINICAL DIAG. & INFO. SYS | Datachem, Inc. | 1983-02-09 | Traditional | PDF ↗ |
| K823762 | VARIOUS-ANALYZER CUPS | Cordis Corp. | 1983-01-12 | Traditional | PDF ↗ |
| K822465 | ENZYMUNE SYSTEM I | Icl Scientific | 1982-09-14 | Traditional | PDF ↗ |
| K821335 | GEMSTAR SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1982-07-13 | Traditional | PDF ↗ |
| K820888 | 8700 CLINICAL CHEM. ANALYZER | Boehringer Mannheim Corp. | 1982-05-14 | Traditional | PDF ↗ |
| K820687 | DUPONT AUTOMATIC CLINICAL ANALYZER | E.I. Dupont DE Nemours & Co., Inc. | 1982-04-01 | Traditional | PDF ↗ |
| K820118 | ELECTROLYTE ANALYZER ACCESSORY | Boehringer Mannheim Corp. | 1982-02-04 | Traditional | PDF ↗ |
| K813160 | BECKMAN SYSTEM E4A | Beckman Instruments, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K813102 | POLI-MAK II | Pm America, Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K811919 | KODAK EKTACHEM 400 ANALYZER | Eastman Kodak Company | 1981-07-23 | Traditional | PDF ↗ |
| K811194 | HITACHI 705 AUTOMATIC BLOOD CHEMISTRY | Boehringer Mannheim Corp. | 1981-05-27 | Traditional | PDF ↗ |
| K810549 | THERMAL PRINTER PAPER | Nobel Scientific Industries, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810596 | CENTRIFI CHEM SYSTEM 400 ANALYZER | Union Carbide Corp. | 1981-03-17 | Traditional | PDF ↗ |
| K810129 | CENTRIFICHEM SYSTEM 500 | Union Carbide Corp. | 1981-02-02 | Traditional | PDF ↗ |
| K803267 | AUTOMATED IMMUOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K803135 | PARALLEL CHEMICAL ANALYZER | American Monitor Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K802835 | COMPU-CHEM II CHEMISTRY ANALYZER | Diagnostic Aids, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K802609 | CHEMISTRY ANALYZER IMPACT 400 | Gilford Instrument Laboratories, Inc. | 1980-11-26 | Traditional | PDF ↗ |
| K802320 | COULTER DACOS SERUM CHEM. ANALYZER | Coulter Electronics, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801889 | MODEL 203S CLINICAL CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K800572 | KDA MICRO CHEMICAL ANALYZER | American Monitor Corp. | 1980-04-02 | Traditional | PDF ↗ |
| K800085 | SYSTEM 203 CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K800053 | KODAK EKTACHEM FOUR CHEMISTRY ANALYZER | Eastman Kodak Company | 1980-01-23 | Traditional | PDF ↗ |
| K792361 | SYSTEM 103 CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | 1979-12-27 | Traditional | PDF ↗ |
| K791297 | PRISMA | Lkb Instruments, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K791296 | CHEMETRICS ANALYZER II | Chemetrics Corp. | 1979-08-03 | Traditional | PDF ↗ |
| K790072 | ANALYZER, IMPACT 200 | Gilford Instrument Laboratories, Inc. | 1979-02-22 | Traditional | PDF ↗ |
| K782014 | ANALYZER ABA-200 | Abbott Laboratories | 1979-01-10 | Traditional | PDF ↗ |
| K781528 | COULTER ELECTROLYTE ANALYZER SYSTEM | Coulter Electronics, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781076 | CHEMISTRY ANALYZER | Johns Scientific, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | Hycel, Inc. | 1978-05-03 | Traditional | PDF ↗ |
Product code JJE · Class I · Clinical Chemistry. Data: openFDA.