FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEBRILE ANTIGENS & CONTROL SERUMS
K Number: K760097
·
Decision Aug 3, 1976
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
21
Review Days
50
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Basic Information
- Device Name
- FEBRILE ANTIGENS & CONTROL SERUMS
- K Number
- K760097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gamma Biologicals, Inc.
- Date Received
- June 14, 1976
- Decision Date
- August 3, 1976
- Product Code
- GSZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 ANTIGEN CONTROL SERA
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Gamma Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Dec 3, 1986 | Substantially Equivalent |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Apr 18, 1986 | Substantially Equivalent |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Aug 16, 1983 | Substantially Equivalent |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | May 12, 1982 | Substantially Equivalent |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Mar 4, 1982 | Substantially Equivalent |
| K820072 | FE-CULT PLUS | Mar 4, 1982 | Substantially Equivalent |
| K811752 | FE-CULT PLUS | Nov 2, 1981 | Substantially Equivalent |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K800658 | RST-SERIES CONTROL | Apr 16, 1980 | Substantially Equivalent |