Panels › Clinical Chemistry › Product code JIS · Class 2
Calibrator, Primary
Regulation 862.1150
0510(k)s in 12 months (130 all time)
0recalls in 12 months (21 all time)
15recalls that name a 510(k)
Top companies in JIS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 1992 | K922698 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Aug 12, 1992 | K922696 | DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Aug 3, 1992 | K921855 | BIOTROL BICARBONATE STANDARDS Biotrol, USA, Inc. | JIS |
| May 26, 1992 | K921903 | THYROXINE CALIBRATOR KIT Tudor Laboratories, Inc. | JIS |
| Apr 17, 1992 | K920809 | KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD King Diagnostics, Inc. | JIS |
| May 6, 1991 | K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS Biotrol, USA, Inc. | JIS |
| Feb 26, 1991 | K905820 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Feb 13, 1991 | K905477 | OLYMPUS URINE PH CALIBRATORS LEVELS I AND II Em Diagnostic Systems, Inc. | JIS |
| Mar 29, 1990 | K901113 | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD Verichem Laboratories, Inc. | JIS |
| Nov 14, 1989 | K895778 | QUANTIMETRIX BILIRUBIN CALIBRATORS Quantimetrix Medical Industries | JIS |
| Nov 13, 1989 | K895585 | HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) Hichem Diagnostics | JIS |
| Nov 29, 1988 | K884168 | ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. The DU Pont Co. | JIS |
| Aug 29, 1988 | K882726 | RAICHEM(TM) BILIRUBIN STANDARD Reagents Applications, Inc. | JIS |
| Jun 7, 1988 | K881693 | TERUMO SENSIBEAD EIA PROGESTERONE KIT Terumo Medical Corp. | JIS |
| Sep 18, 1987 | K872051 | CALCIUM CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| May 28, 1987 | K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 In Vitro Diagnostics, Inc. | JIS |
| May 28, 1987 | K871187 | LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 In Vitro Diagnostics, Inc. | JIS |
| May 28, 1987 | K871186 | CESIUM DILUENT 1.5 MMOL CS/L #60087 In Vitro Diagnostics, Inc. | JIS |
| May 28, 1987 | K871185 | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 In Vitro Diagnostics, Inc. | JIS |
| Feb 26, 1987 | K870379 | ISE COMPENSATION SERA Boehringer Mannheim Corp. | JIS |
| Aug 19, 1986 | K862704 | EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 Em Diagnostic Systems, Inc. | JIS |
| Aug 19, 1986 | K862453 | EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 Em Diagnostic Systems, Inc. | JIS |
| Jun 25, 1986 | K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861769 | GENTAMICIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jan 22, 1986 | K855040 | SERALYZER TOTAL BILIRUBIN CALIBRATORS Miles Laboratories, Inc. | JIS |
| May 31, 1985 | K852068 | TOTAL BILIRUBIN STANDARDS Data Medical Associates, Inc. | JIS |
| Dec 12, 1984 | K844581 | 80 MG/DL GLUCOSE CONTROL Boehringer Mannheim Corp. | JIS |
| Nov 20, 1984 | K844235 | CHLORIDE STANDARD Shaban Mfg. Co. | JIS |
| Sep 4, 1984 | K843110 | ROCHE STANDARDS FOR CHOLESTEROL Roche Diagnostic Systems, Inc. | JIS |
| Aug 16, 1984 | K842450 | HICHEM ION 2/4 URINE RANGE CALIBRATOR Hi Chem, Inc. | JIS |
| Aug 16, 1984 | K842449 | HICHEM ION 2/4 SERUM RANGE CALIBRATOR Hi Chem, Inc. | JIS |
| Jun 25, 1984 | K841955 | DUPONT ACA MAGNESIUM CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Mar 23, 1984 | K840299 | PH ELECTRODE CALIBRATING BUFFERS-BLOOD Bionostics, Inc. | JIS |
| Mar 23, 1984 | K840220 | HDL CHOLESTEROL AQUEOUS STANDARDS Preventive Diagnostics Corp. | JIS |
| Mar 23, 1984 | K840217 | CHOLESTEROL AQUEOUS STANDARD Preventive Diagnostics Corp. | JIS |
| Aug 24, 1983 | K832251 | PRECISET CHOLESTEROL HIGH PERFORM Boehringer Mannheim Corp. | JIS |
| Feb 28, 1983 | K830283 | LITHIUM DILUENT Shaban Mfg. Co. | JIS |
| Feb 7, 1983 | K830137 | CALIBRATOR A Hi Chem, Inc. | JIS |
| Nov 22, 1982 | K823147 | URIC ACID STANDARD, 8MG/DL #65078 Harleco Diagnostics | JIS |
| Sep 17, 1982 | K822477 | CREATININE STANDARD #65072 Emd Chemicals, Inc. | JIS |
| Sep 17, 1982 | K822473 | CALCIUM STANDARD, ITEM #65075 Emd Chemicals, Inc. | JIS |
| Sep 14, 1982 | K822476 | PHOSPHOROUS STANDARD #65073 Emd Chemicals, Inc. | JIS |
| Sep 14, 1982 | K822474 | CHOLESTEROL STANDARD #65077 Emd Chemicals, Inc. | JIS |
| Aug 16, 1982 | K822332 | C-REACTIVE PROTEIN TEST KIT Sclavo, Inc. | JIS |
| Aug 16, 1982 | K822232 | ACA URINARY PROTEIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Jul 20, 1982 | K821934 | BIO-CAL OPERATION CHECK KIT Bio-Analytics Laboratories, Inc. | JIS |
| Jul 16, 1982 | K821938 | SYVA ADVANCE STANDARDIZATION KIT #3 Syva Co. | JIS |
| Jul 16, 1982 | K821937 | SYVA ADVANCE STANDARDIZATION KIT #2 Syva Co. | JIS |
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