CELL-DYN CALIBRATOR
FDA 510(k) clearance K902892 · decided 1990-09-10
Clearance details
- K-number
- K902892
- Device name
- CELL-DYN CALIBRATOR
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-02
- Decision date
- 1990-09-10
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KRZ
- Device class
- 2
- Regulation number
- 864.8165
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Unipath
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101) | Roche Diagnostics | 2005-08-26 |
| CDS HEMATOLOGY CALIBRATOR (CDS CAL) (K041130) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 |
| THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (K962864) | Alko Diagnostic Corp. | 1996-12-18 |
| ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (K951071) | Alko Diagnostic Corp. | 1995-07-24 |
| RAICHEM TM HEMOGLOBIN CALIBRATOR (K896921) | Reagents Applications, Inc. | 1990-01-25 |
| HGB-CAL SET/MULTIPLE (K893984) | R&D Systems, Inc. | 1989-08-15 |
| MSI-CAL 16 (K883850) | Medical Specialties, Inc. | 1988-11-22 |
| MSI-CAL 7 (K883703) | Medical Specialties, Inc. | 1988-11-22 |
| MSI-CAL 8 (K883851) | Medical Specialties, Inc. | 1988-11-22 |
| HEMOCUE HEMOGLOBIN CALIBRATOR (K882600) | React and Co. | 1988-07-18 |
| REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (K873832) | In Vitro Diagnostics, Inc. | 1987-11-23 |
| CYANMETHEMOGLOBIN STANDARD (K871283) | U. S. Diagnostics, Inc. | 1987-04-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN h recall (Z-0246-2007) | Abbott Laboratories | 2006-12-05 |