HEMOCHRON(R) HEPARIN RESPONSE TEST— 510(k) K904003
Substantially EquivalentIntensive Technology, Inc.
FDA 510(k) clearance K904003 for HEMOCHRON(R) HEPARIN RESPONSE TEST, Substantially Equivalent on 1990-11-29. Applicant: Intensive Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Intensive Technology, Inc.
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
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More clearances from Intensive Technology, Inc.
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