FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPECTROLYSE PLASMINOGEN SK KIT
K Number: K912025
·
Decision Aug 22, 1991
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
13
Review Days
107
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Basic Information
- Device Name
- SPECTROLYSE PLASMINOGEN SK KIT
- K Number
- K912025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biopool AB
- Date Received
- May 7, 1991
- Decision Date
- August 22, 1991
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Biopool AB
| K Number | Device Name | ||
|---|---|---|---|
| K941752 | SPECTROLYSE ANTIPLASMIN KIT | Sep 25, 1995 | Unknown |
| K942087 | BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES | Jul 13, 1995 | Substantially Equivalent |
| K934314 | TINTELIZER(R) TPA | Feb 23, 1994 | Substantially Equivalent |
| K923499 | SPECTROLYSE HEPARIN KIT | Jan 27, 1994 | Substantially Equivalent |
| K932463 | BIOCLOT LA | Sep 27, 1993 | Substantially Equivalent |
| K920668 | MINUTEX D-DIMER LATEX TEST | Oct 16, 1992 | Substantially Equivalent |
| K922782 | SPECTROLYSE/PL PAI KIT | Oct 9, 1992 | Substantially Equivalent |
| K915163 | PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES | Jan 6, 1992 | Substantially Equivalent |
| K914307 | SPECTROLYSE PROTEIN C KIT | Dec 9, 1991 | Substantially Equivalent |
| K902566 | BIOPOOL PROTEIN C EID KIT AND BULK PLATES | Aug 9, 1990 | Substantially Equivalent |