FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K Number: K861049
·
Decision May 29, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
188
Applicant Total
231
Review Days
71
Basic Information
- Device Name
- HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
- K Number
- K861049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- SIGMA CHEMICAL CO.
- Date Received
- March 19, 1986
- Decision Date
- May 29, 1986
- 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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|---|---|---|---|
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| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |