FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K Number: K943811
·
Decision Nov 2, 1994
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
79
Applicant Total
49
Review Days
89
Basic Information
- Device Name
- ENZYME-LINKED FLUORESCENT IMMUNOASSAY
- K Number
- K943811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMERIEUX VITEK, INC.
- Date Received
- August 5, 1994
- Decision Date
- November 2, 1994
- 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 BIOMERIEUX VITEK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |