FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
K Number: K853067
·
Decision Oct 22, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
5
Review Days
92
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Basic Information
- Device Name
- FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
- K Number
- K853067
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Idt, A Division of Whittaker M.A. Bioproducts
- Date Received
- July 22, 1985
- Decision Date
- October 22, 1985
- Product Code
- GRE
- 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 |
|---|---|---|---|
| GRE | Antiserum, Fluorescent, Rubeola | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRE), ordered by most recent decision date.
RUBEOLA TEST
FDA 510(k)
FDA Class 1
·Microbiology
ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
FDA 510(k)
FDA Class 1
·Microbiology
MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Idt, A Division of Whittaker M.A. Bioproducts
| K Number | Device Name | ||
|---|---|---|---|
| K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | Feb 4, 1986 | Substantially Equivalent |
| K782041 | FIAX TEST KIT | Jan 3, 1979 | Substantially Equivalent |
| K772219 | FIAX TEST FOR ANTI-RUBELLA ANTIBODY | Jan 20, 1978 | Substantially Equivalent |
| K772114 | FIAX C4 ASSAY | Nov 30, 1977 | Substantially Equivalent |