HEMOCHRON CITRATE APTT
FDA 510(k) clearance K972831 · decided 1997-11-20
Clearance details
- K-number
- K972831
- Device name
- HEMOCHRON CITRATE APTT
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-30
- Decision date
- 1997-11-20
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- GFO
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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| CARESIDE APTT (K014028) | Careside Hemotology, Inc. | 2002-02-08 |
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| SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712) | Sigma Diagnostics, Inc. | 1999-12-06 |
| SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711) | Sigma Diagnostics, Inc. | 1999-12-06 |
| IL TEST APTT-SP (K973306) | Instrumentation Laboratory CO | 1997-11-04 |
Recalls involving this device
No recalls on record reference this clearance.