S-CAL HEMATOLOGY CALIBRATOR
FDA 510(k) clearance K840794 · decided 1984-04-04
Clearance details
- K-number
- K840794
- Device name
- S-CAL HEMATOLOGY CALIBRATOR
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-23
- Decision date
- 1984-04-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- KRY
- Device class
- 2
- Regulation number
- 864.8175
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| S-CAL HEMATOLOGY CALIBRATOR (K862122) | Coulter Electronics, Inc. | 1987-05-20 |
| LASER PLATELETCAL/MULTIPLE (K852016) | R&D Systems, Inc. | 1985-07-09 |
| COULTER MEAN PLATELET VOLUME CALIBRATOR (K843910) | Coulter Electronics, Inc. | 1985-01-07 |
| CONTROL DIAGNOSTICS PLATELET CONTROL (K821851) | Immunogenetics | 1982-09-02 |
| TEKNI-CAL (K781601) | Streck Laboratories, Inc. | 1978-10-10 |
| PC-CALIBRATOR (K781133) | Streck Laboratories, Inc. | 1978-08-14 |
| TQC CALIBRATION REFERENCE FOR PLATELETS (K770143) | Technicon Instruments Corp. | 1978-01-30 |
Recalls involving this device
No recalls on record reference this clearance.