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
- Product 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
Recent devices under product code KFF
view all- K260214 — STA® - Liquid Anti-Xa
- K213464 — HemosIL Liquid Anti-Xa
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
More clearances from Intensive Technology, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.