FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEBRILE ANTIGEN CONTROL SERA
K Number: K760881
·
Decision Nov 9, 1976
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
632
Review Days
19
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Basic Information
- Device Name
- FEBRILE ANTIGEN CONTROL SERA
- K Number
- K760881
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- October 21, 1976
- Decision Date
- November 9, 1976
- Product Code
- GSZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| GSZ | Antigens, Febrile (Weil-Felix), All Groups | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GSZ), ordered by most recent decision date.
PROTEUS OX-19 IFA*
FDA 510(k)
FDA Class 1
·Microbiology
FEBRILE ANTIGENS & CONTROL SERUMS
FDA 510(k)
FDA Class 1
·Microbiology
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| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
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