Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRZ · Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
148 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052101 | C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | Roche Diagnostics | 2005-08-26 | 23 | 0 |
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 | 41 | 0 |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | 1996-12-18 | 148 | 0 |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZ | Alko Diagnostic Corp. | 1995-07-24 | 138 | 0 |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | 1990-09-10 | 70 | 1 |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | 1990-01-25 | 45 | 0 |
| K893984 | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 | 71 | 0 |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | 1988-07-18 | 24 | 0 |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | 1987-11-23 | 63 | 0 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | 1987-04-15 | 15 | 0 |
| K854166 | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | 1986-03-12 | 148 | 0 |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | 1985-03-05 | 238 | 0 |
| K843695 | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-17 | 89 | 0 |
| K840010 | DADE HEMATOLOGY CALIBRATOR PLUS | American Dade | 1984-04-19 | 106 | 0 |
| K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR | Streck Laboratories, Inc. | 1984-02-21 | 47 | 1 |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | United Diagnostics, Inc. | 1983-07-28 | 52 | 0 |
| K831872 | CALIBRATOR 282 | Bionostics, Inc. | 1983-07-18 | 35 | 0 |
| K831306 | HEMACAL | Hematology Marketing Assoc. | 1983-06-16 | 55 | 0 |
| K822327 | CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT | Interscience, Inc. | 1982-11-16 | 105 | 0 |
| K822046 | SERALYZER HEMOGLOBIN CALIBRATORS | Miles Laboratories, Inc. | 1982-07-30 | 18 | 0 |
| K800852 | HEMESPEC CHECK SET | Helena Laboratories | 1980-05-02 | 17 | 0 |
| K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD | Sandare Chemical Co., Inc. | 1979-12-31 | 40 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda