TRI-COUNT CALIBRATOR
FDA 510(k) clearance K844708 · decided 1985-03-05
Clearance details
- K-number
- K844708
- Device name
- TRI-COUNT CALIBRATOR
- Applicant
- Hematology Marketing Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-03
- Decision date
- 1985-03-05
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- KSA
- Device class
- 2
- Regulation number
- 864.8185
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hematology Marketing Assoc.
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 |
|---|---|---|
| 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 |
| H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (K864664) | Technicon Instruments Corp. | 1987-02-06 |
| CBC-CAL/MULTIPLE (K854823) | R&D Systems, Inc. | 1986-02-13 |
| 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.