HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
FDA 510(k) clearance K960749 · decided 1996-08-12
Clearance details
- K-number
- K960749
- Device name
- HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-23
- Decision date
- 1996-08-12
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the recall (Z-0880-2026) | Accriva Diagnostics, Inc. | 2025-12-03 |
| Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For recall (Z-1732-2009) | International Technidyne Corp. | 2009-08-21 |
| Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-L recall (Z-1381-05) | International Technidyne Corp. | 2005-08-23 |