H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
FDA 510(k) clearance K864664 · decided 1987-02-06
Clearance details
- K-number
- K864664
- Device name
- H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-28
- Decision date
- 1987-02-06
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KSA
- Device class
- 2
- Regulation number
- 864.8185
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (K943268) | Streck Laboratories, Inc. | 1994-12-15 |
| CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE (K897060) | R&D Systems, Inc. | 1990-01-02 |
| TECH-CAL(TM)/MULTIPLE (K881161) | R&D Systems, Inc. | 1988-05-02 |
| CBC-CAL/MULTIPLE (K854823) | R&D Systems, Inc. | 1986-02-13 |
| TRI-COUNT CALIBRATOR (K844708) | Hematology Marketing Assoc. | 1985-03-05 |
| HEMOTOLOGY CALIBRATOR (K813530) | American Dade | 1982-02-22 |
| HEMATOLOGY CALIBRATOR S-CAL (K813375) | Coulter Electronics, Inc. | 1982-02-04 |
Recalls involving this device
No recalls on record reference this clearance.