FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FTA-ABS TEST SYSTEM
K Number: K781403
·
Decision Aug 21, 1978
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
135
Review Days
6
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Basic Information
- Device Name
- FTA-ABS TEST SYSTEM
- K Number
- K781403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- August 15, 1978
- Decision Date
- August 21, 1978
- Product Code
- GMS
- 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 |
|---|---|---|---|
| GMS | Anti-Human Globulin, Fta-Abs Test | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMS), ordered by most recent decision date.
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
FDA 510(k)
FDA Class 2
·Microbiology
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
FDA 510(k)
FDA Class 2
·Microbiology
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