FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
CYBERFLUOR 615 IMMUNOANALYZER
K Number: K872803
·
Decision Sep 2, 1987
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
37
Applicant Total
17
Review Days
49
Basic Information
- Device Name
- CYBERFLUOR 615 IMMUNOANALYZER
- K Number
- K872803
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CYBERFLUOR, INC.
- Date Received
- July 15, 1987
- Decision Date
- September 2, 1987
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| K883182 | FIAGEN RUBELLA IGG | Oct 31, 1988 | Substantially Equivalent |