FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FLAGEN TM FREE T4
K Number: K904539
·
Decision Nov 30, 1990
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
17
Review Days
57
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Basic Information
- Device Name
- FLAGEN TM FREE T4
- K Number
- K904539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cyberfluor, Inc.
- Date Received
- October 4, 1990
- Decision Date
- November 30, 1990
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K895396 | CYBERFLUOR FIAGEN TSH | Oct 31, 1989 | Substantially Equivalent |
| K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Jan 17, 1989 | Substantially Equivalent |
| K884707 | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Jan 17, 1989 | Substantially Equivalent |
| K884201 | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Dec 14, 1988 | Substantially Equivalent |
| K883182 | FIAGEN RUBELLA IGG | Oct 31, 1988 | Substantially Equivalent |
| K882823 | FIAGEN HGH FLUOROIMMUNOASSAY KIT | Aug 30, 1988 | Substantially Equivalent |