FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPECTROLYSE ATIII KIT
K Number: K902530
·
Decision Aug 9, 1990
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
55
Applicant Total
13
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPECTROLYSE ATIII KIT
- K Number
- K902530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biopool AB
- Date Received
- June 5, 1990
- Decision Date
- August 9, 1990
- Product Code
- JBQ
- 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 |
|---|---|---|---|
| JBQ | Antithrombin Iii Quantitation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBQ), ordered by most recent decision date.
INNOVANCE Antithrombin
FDA 510(k)
FDA Class 2
·Hematology
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
FDA 510(k)
FDA Class 2
·Hematology
HEMOSIL ANTITHROMBIN
FDA 510(k)
FDA Class 2
·Hematology
HEMOSIL LIQUID ANTITHROMBIN
FDA 510(k)
FDA Class 2
·Hematology
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
FDA 510(k)
FDA Class 2
·Hematology
HEMOSIL LIQUID ANTITHROMBIN XL
FDA 510(k)
FDA Class 2
·Hematology
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 |
| K912025 | SPECTROLYSE PLASMINOGEN SK KIT | Aug 22, 1991 | Substantially Equivalent |