FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-COUNT 20
K Number: K960471
·
Decision Mar 20, 1996
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
9
Review Days
48
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Basic Information
- Device Name
- TRI-COUNT 20
- K Number
- K960471
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hematronix, Inc.
- Date Received
- February 1, 1996
- Decision Date
- March 20, 1996
- Product Code
- JPK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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Other Clearances by Hematronix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012243 | MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL | Aug 20, 2001 | Substantially Equivalent |
| K993496 | RETIC-QUINOX | Nov 30, 1999 | Substantially Equivalent |
| K972710 | QUANTIFY(901) | Aug 15, 1997 | Substantially Equivalent |
| K960005 | TRI-COURT 20-T | Mar 19, 1996 | Substantially Equivalent |
| K941965 | EZ-RANGE | Apr 25, 1995 | Substantially Equivalent |
| K935343 | CENTRIFIQ BLOOD CONTROL | Jan 27, 1994 | Substantially Equivalent |
| K904461 | METER TRAX | Oct 26, 1990 | Substantially Equivalent |
| K902389 | TRI-COUNT 16 | Aug 22, 1990 | Substantially Equivalent |