FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD GROUP SUBSTANCE B
K Number: K781895
·
Decision Dec 20, 1978
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
6
Review Days
44
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Basic Information
- Device Name
- BLOOD GROUP SUBSTANCE B
- K Number
- K781895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9160
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- North American Biologicals, Inc.
- Date Received
- November 6, 1978
- Decision Date
- December 20, 1978
- Product Code
- KSX
- 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 |
|---|---|---|---|
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSX), ordered by most recent decision date.
GAMMA LEWIS BLOOD GROUP SUBSTANCE
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GAMMA PI BLOOD GROUP SUBSTANCE
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P1 BLOOD GROUP SUBSTANCE
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BLOOD GROUP SUBSTANCE A
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BLOOD GROUP SUBSTANCE A,B
FDA 510(k)
FDA Class 2
·Hematology
LEWIS BLOOD GROUP SUBSTANCE
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by North American Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | Apr 9, 1982 | Substantially Equivalent |
| K801219 | PLASMAPOOLER | Oct 31, 1980 | Substantially Equivalent |
| K801425 | RH CONTROL | Jul 14, 1980 | Substantially Equivalent |
| K781862 | BLOOD GROUP SUBSTANCE A | Dec 20, 1978 | Substantially Equivalent |
| K781896 | BLOOD GROUP SUBSTANCE A,B | Dec 20, 1978 | Substantially Equivalent |