QCA HEMOGLOBIN KIT
FDA 510(k) clearance K843695 · decided 1984-12-17
Clearance details
- K-number
- K843695
- Device name
- QCA HEMOGLOBIN KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1984-09-19
- Decision date
- 1984-12-17
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KRZ
- Device class
- 2
- Regulation number
- 864.8165
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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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 |
| CELL-DYN CALIBRATOR (K902892) | Unipath , Ltd. | 1990-09-10 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |