Panels › Hematology › Product code KRZ · Class 2
Calibrator For Hemoglobin And Hematocrit Measurement
Regulation 864.8165
0510(k)s in 12 months (25 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KRZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2005 | K052101 | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C Roche Diagnostics | KRZ |
| Jun 10, 2004 | K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) Clinical Diagnostic Solutions, Inc. | KRZ |
| Dec 18, 1996 | K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS Alko Diagnostic Corp. | KRZ |
| Jul 24, 1995 | K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS Alko Diagnostic Corp. | KRZ |
| Sep 10, 1990 | K902892 | CELL-DYN CALIBRATOR Unipath , Ltd. | KRZ |
| Jan 25, 1990 | K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR Reagents Applications, Inc. | KRZ |
| Aug 15, 1989 | K893984 | HGB-CAL SET/MULTIPLE R&D Systems, Inc. | KRZ |
| Nov 22, 1988 | K883851 | MSI-CAL 8 Medical Specialties, Inc. | KRZ |
| Nov 22, 1988 | K883850 | MSI-CAL 16 Medical Specialties, Inc. | KRZ |
| Nov 22, 1988 | K883703 | MSI-CAL 7 Medical Specialties, Inc. | KRZ |
| Jul 18, 1988 | K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR React and Co. | KRZ |
| Nov 23, 1987 | K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 In Vitro Diagnostics, Inc. | KRZ |
| Apr 15, 1987 | K871283 | CYANMETHEMOGLOBIN STANDARD U. S. Diagnostics, Inc. | KRZ |
| Mar 12, 1986 | K854166 | HEMATOLOGY CALIBRATOR CONTROL Interscience Diagnostics, Inc. | KRZ |
| Mar 5, 1985 | K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS Biodiagnostic Intl | KRZ |
| Dec 17, 1984 | K843695 | QCA HEMOGLOBIN KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | KRZ |
| Apr 19, 1984 | K840010 | DADE HEMATOLOGY CALIBRATOR PLUS American Dade | KRZ |
| Feb 21, 1984 | K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR Streck Laboratories, Inc. | KRZ |
| Jul 28, 1983 | K831814 | CALIBRATION STANDARD-HEMOGLOBIN United Diagnostics, Inc. | KRZ |
| Jul 18, 1983 | K831872 | CALIBRATOR 282 Bionostics, Inc. | KRZ |
| Jun 16, 1983 | K831306 | HEMACAL Hematology Marketing Assoc. | KRZ |
| Nov 16, 1982 | K822327 | CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT Interscience, Inc. | KRZ |
| Jul 30, 1982 | K822046 | SERALYZER HEMOGLOBIN CALIBRATORS Miles Laboratories, Inc. | KRZ |
| May 2, 1980 | K800852 | HEMESPEC CHECK SET Helena Laboratories | KRZ |
| Dec 31, 1979 | K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD Sandare Chemical Co., Inc. | KRZ |
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