FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K Number: K970607
·
Decision Apr 25, 1997
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
78
Applicant Total
8
Review Days
66
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Basic Information
- Device Name
- UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
- K Number
- K970607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Universal Reagents, Inc.
- Date Received
- February 18, 1997
- Decision Date
- April 25, 1997
- Product Code
- GJT
- 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 |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | FDA class 2 | Hematology |
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Other Clearances by Universal Reagents, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973143 | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA | Sep 25, 1997 | Substantially Equivalent |
| K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) | Jul 14, 1997 | Substantially Equivalent |
| K972288 | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) | Jul 14, 1997 | Substantially Equivalent |
| K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA | Apr 25, 1997 | Substantially Equivalent |
| K964270 | UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA | Dec 18, 1996 | Substantially Equivalent |
| K964459 | UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA | Dec 18, 1996 | Substantially Equivalent |
| K961929 | FACTOR DEFICIENT PLASMA | Oct 10, 1996 | Substantially Equivalent |