FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K Number: K874621
·
Decision Jan 11, 1988
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
79
Applicant Total
17
Review Days
62
Basic Information
- Device Name
- FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
- K Number
- K874621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CYBERFLUOR, INC.
- Date Received
- November 10, 1987
- Decision Date
- January 11, 1988
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFT), ordered by most recent decision date.
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS PROLACTIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |