FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FIAGEN RUBELLA IGG
K Number: K883182
·
Decision Oct 31, 1988
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
17
Review Days
95
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Basic Information
- Device Name
- FIAGEN RUBELLA IGG
- K Number
- K883182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Cyberfluor, Inc.
- Date Received
- July 28, 1988
- Decision Date
- October 31, 1988
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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Other Clearances by Cyberfluor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923410 | FIAGEN PROGESTERONE | Dec 3, 1992 | Substantially Equivalent |
| K905656 | FLAGEN TRIIODOTHYRONINE (T3) ASSAY | Jan 23, 1991 | Substantially Equivalent |
| K904539 | FLAGEN TM FREE T4 | Nov 30, 1990 | Substantially Equivalent |
| K900621 | FIAGEN(TM) HLH.S | Mar 1, 1990 | Substantially Equivalent |
| K895186 | FIAGEN T3 UPTAKE CATALOGUE #101-402 | Nov 8, 1989 | Substantially Equivalent |
| 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 |
| K882823 | FIAGEN HGH FLUOROIMMUNOASSAY KIT | Aug 30, 1988 | Substantially Equivalent |