FDA Product Code
FDA Product Code JIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 302 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K875282 | QM300 CALIBRATOR B PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K875304 | BIOTROL CALIBRANT LEVEL 2 | Biotrol, USA, Inc. | 1988-02-03 | Traditional | PDF ↗ |
| K875318 | BIOTROL CALIBRANT LEVEL 3 | Biotrol, USA, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K875288 | BIOTROL CALIBRANT LEVEL 1 | Biotrol, USA, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K874413 | REAGENT A AND REAGENT B | Seradyn, Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K874587 | PARAMAX URINE/CSF CALIBRATOR | Baxter Healthcare Corp | 1988-01-05 | Traditional | PDF ↗ |
| K871755 | PROTEIN STANDARD CALIBRATOR | Wako Chemicals USA, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K873116 | MULTI ANALYTE MIXTURES, CALIBRATORS | Biotrol, USA, Inc. | 1987-09-02 | Traditional | PDF ↗ |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | American Dade | 1987-09-02 | Traditional | PDF ↗ |
| K873118 | BIOTROL REFERENCE | Biotrol, USA, Inc. | 1987-09-02 | Traditional | PDF ↗ |
| K871184 | FLAME PHOTOMETER STANDARD #60083 160 NA/8K | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871183 | FLAME PHOTOMETER STANDARD #60082 140 NA/5K | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871182 | FLAME PHOTOMETER STANDARD #60081 120 NA/2K | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871341 | QM300 CALIBRATOR A PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-21 | Traditional | PDF ↗ |
| K871638 | EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 | Em Diagnostic Systems, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K871664 | IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR | Instrumentation Laboratory CO | 1987-05-08 | Traditional | PDF ↗ |
| K864909 | DU PONT LIQUID MULTI-ANALYTE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L | Reagent Laboratory, Inc. | 1986-10-21 | Traditional | PDF ↗ |
| K863489 | PARAMAX ELECTROLYTE CALIBRATOR | American Dade | 1986-09-29 | Traditional | PDF ↗ |
| K863095 | ACE II (TRI-LEVEL) | Medical Analysis Systems, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K862594 | SERACON(TM) CAL (PRODUCT NO. DO35) | Bhp Diagnostix, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862703 | EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 | Em Diagnostic Systems, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K861786 | DU PONT DRUG CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K860765 | EMDS CHEMISTRY CALIBRATORS, LEVELS I & II | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | Kallestad Laboratories, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K855199 | PARAMAX COMPREHENSIVE CALIBRATOR | American Dade | 1986-02-19 | Traditional | PDF ↗ |
| K854092 | DMA CALIBRATORS | Data Medical Associates, Inc. | 1985-10-25 | Traditional | PDF ↗ |
| K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU | Alpkem Corp. | 1985-06-25 | Traditional | PDF ↗ |
| K851939 | CORNING CERTAIN -ISE | Corning Medical & Scientific | 1985-06-14 | Traditional | PDF ↗ |
| K851150 | FISHER DIAGNOSTICS KDA CALIBRATOR I | Fisher Scientific Co., LLC | 1985-05-20 | Traditional | PDF ↗ |
| K851151 | FISHER DIAGNOSTICS KDA CALIBRATOR II | Fisher Scientific Co., LLC | 1985-05-20 | Traditional | PDF ↗ |
| K850859 | COBAS CALIBRATOR SERUM | Roche Diagnostic Systems, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K850405 | CALIBRATOR B 88133 | Hi Chem, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K850396 | ROCHE STANDARDS FOR CHLORIDE & CO2 | Roche Diagnostic Systems, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K844709 | CRITIC-ARS | Dimension Diagnostics | 1985-01-08 | Traditional | PDF ↗ |
| K844344 | GEMCAL ENI REFERENCE SERUM | Biocell Laboratories, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K844585 | REFERRIL CALIBRATORS | Instrumentation Laboratory CO | 1984-12-11 | Traditional | PDF ↗ |
| K844027 | SERACON TM SR III | Bhp Diagnostix, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K844026 | SERACON TM SR IV | Bhp Diagnostix, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843947 | DOUMENT TM LINEARITY TEST STANDARDS | Casco Standards | 1984-10-17 | Traditional | PDF ↗ |
| K841464 | CHANGES IN THE CHEMICAL COMP. OF 5 | Nova Biomedical Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K841456 | VENTREXYME EIA CONTROLS IMMUNOASSAY | Vxr, Inc. | 1984-05-21 | Traditional | PDF ↗ |
| K841419 | SODIUM & POTASSIUM STANDARD SOLUT | Reagent Laboratory, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841420 | SODIUM & POTASSIUM STANDARD SOL 80 | Reagent Laboratory, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K840219 | TRIGLYCERIDE/CHOLESTEROL AQUEOUS | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K840278 | HDL CHOLESTEROL CONTROLS-LEVELS | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K833005 | PARAMAX BILIRUBIN CALIBRATORS | American Dade | 1983-11-14 | Traditional | PDF ↗ |
| K832695 | LYPHOCHEK SERUM REF. STANDARD-BOVINE | Bio-Rad | 1983-10-04 | Traditional | PDF ↗ |
| K832046 | SERALYZER MULTICOMPONENT CALIBRATORS | Miles Laboratories, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K831030 | COBAS STANDARDS FOR GLUCOSE & BUN | Roche Diagnostic Systems, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830341 | SALT BRIDGE SOLUTION & URINE DILUENT | Shaban Mfg. Co. | 1983-03-10 | Traditional | PDF ↗ |
| K823044 | KM-KAL L3 | Kmn Products, Inc. | 1982-12-09 | Traditional | PDF ↗ |
| K823043 | KM-KAL L2 | Kmn Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K823042 | KM-KAL L1 | Kmn Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K823045 | KM-KAL L4 | Kmn Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K823046 | KM-KAL L5 | Kmn Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822937 | GLUCOSE/UREA NITROGEN STANDARD | Emd Chemicals, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822289 | CO2/CI STANDARDS | Gilford Diagnostics | 1982-08-24 | Traditional | PDF ↗ |
| K821885 | REF. ELECTRODE SOL'N.;STANDARD B | Avl Scientific Corp. | 1982-07-13 | Traditional | PDF ↗ |
| K821794 | NOVA V FLUIDS PACK & EXTERNAL STANDARDS | Shaban Mfg. Co. | 1982-07-02 | Traditional | PDF ↗ |
| K821623 | NOVA IV FLUIDS PACK & EXTERNAL STANDARDS | Shaban Mfg. Co. | 1982-06-14 | Traditional | PDF ↗ |
| K821030 | NOVA II FLUIDS PACK | Shaban Mfg. Co. | 1982-05-03 | Traditional | PDF ↗ |
| K820947 | NOVA III FLUIDS PACK | Shaban Mfg. Co. | 1982-04-26 | Traditional | PDF ↗ |
| K820700 | EXTERNAL STANDARDS-SODIUMNPOTASSIUM | Shaban Mfg. Co. | 1982-04-01 | Traditional | PDF ↗ |
| K820701 | NOVA I FLUIDS PACK | Shaban Mfg. Co. | 1982-04-01 | Traditional | PDF ↗ |
| K813127 | SODIUM & POTASSIUM PRODUCTS | Alko Diagnostic Corp. | 1982-01-22 | Traditional | PDF ↗ |
| K813411 | DOCUMENT LINEARITY TEST STANDARDS | North American Standards | 1981-12-18 | Traditional | PDF ↗ |
| K812649 | BECKMAN ICS CALIBRATOR | Beckman Instruments, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K811921 | HITACHI 705 CALIBRATOR | Boehringer Mannheim Corp. | 1981-07-23 | Traditional | PDF ↗ |
| K810964 | BIO SET TM PHOSPHOROUS CALIBRATOR | Boehringer Mannheim Corp. | 1981-04-17 | Traditional | PDF ↗ |
| K803051 | FLAME PHOTOMETRY REAGENTS | Laboratory Products, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802824 | COMBUNED CALCIUM AND PHOSPHORUS STD. | Mallinckrodt Critical Care | 1980-12-11 | Traditional | PDF ↗ |
| K802632 | ALBUMIN/TOTAL PROTEIN STANDARDS | Gilford Diagnostics | 1980-12-11 | Traditional | PDF ↗ |
| K802633 | BUN/GLUCOSE STANDARDS | Gilford Diagnostics | 1980-12-11 | Traditional | PDF ↗ |
| K802825 | COMBINED GLUCOSE AND BUN STANDARDS | Mallinckrodt Critical Care | 1980-12-11 | Traditional | PDF ↗ |
| K802741 | CENTRIFICHEM COMB. SERUM-BASED CALIB. | Union Carbide Corp. | 1980-12-10 | Traditional | PDF ↗ |
| K801222 | REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER | Simmler, Inc. | 1980-06-26 | Traditional | PDF ↗ |
| K800910 | GAL-PUT CONTROLS, NORMAL&DEFICIENT | Sigma Chemical Co. | 1980-04-29 | Traditional | PDF ↗ |
| K800040 | SODIUM/POTASSIUM (100/100 MEQ/E) | Gilford Diagnostics | 1980-01-21 | Traditional | PDF ↗ |
| K800041 | SODIUM/POTASSIUM 140/5 MEQ/L) | Gilford Diagnostics | 1980-01-21 | Traditional | PDF ↗ |
| K800043 | CESIUM DILUENT (1.5 MM/L) | Gilford Diagnostics | 1980-01-21 | Traditional | PDF ↗ |
| K792487 | SERACON-SRII | Bhp Diagnostix, Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K792485 | SERACON-SRI | Bhp Diagnostix, Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K792486 | SERACON-SRI (PROD. # D029 | Bhp Diagnostix, Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K792384 | PRINCIPAL ANALYTE REFERENCE SERUM | Beckman Instruments, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Sherwood Medical Industries | 1979-11-13 | Traditional | PDF ↗ |
| K791874 | CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD | Gilford Diagnostics | 1979-10-17 | Traditional | PDF ↗ |
| K791956 | SERACON CAL D025 | Bhp Diagnostix, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791693 | CALIBRATOR I | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791694 | CALIBRATOR II | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K782039 | SERACON-N | Bhp Diagnostix, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K782037 | SERACON-A | Bhp Diagnostix, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781757 | SERACON-SRI | Bhp Diagnostix, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781758 | SERACON-SRII | Bhp Diagnostix, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781702 | CALIBRATOR, BOVINE SERUM | Bio-Reagents & Diagnostics, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K780553 | COMP. CLIN. CHEM. REF. SERUM-BENCHMARK | Beckman Instruments, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K770010 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-18 | Traditional | PDF ↗ |
| K770012 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-18 | Traditional | PDF ↗ |
| K770011 | Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-18 | Traditional | PDF ↗ |
| K770494 | BLOOD GAS ANALYZER-CALIBRATION GAS | Gardner Cryogenics | 1977-04-15 | Traditional | PDF ↗ |
Product code JIX · Class II · Clinical Chemistry. Data: openFDA.