FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTICONVULSANTS III CALIBRATOR KIT
K Number: K780733
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
39
Review Days
51
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Basic Information
- Device Name
- ANTICONVULSANTS III CALIBRATOR KIT
- K Number
- K780733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Vitek Systems, Inc.
- Date Received
- May 2, 1978
- Decision Date
- June 22, 1978
- Product Code
- DKH
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DKH | Gas Chromatography, Diphenylhydantoin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKH), ordered by most recent decision date.
View allOther Clearances by Vitek Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920661 | VIDAS CMV IGG ASSAY | Feb 12, 1993 | Substantially Equivalent |
| K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Jul 28, 1992 | Substantially Equivalent |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Apr 8, 1992 | Substantially Equivalent |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | Apr 7, 1992 | Substantially Equivalent |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | Oct 11, 1991 | Substantially Equivalent |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Sep 23, 1991 | Substantially Equivalent |
| K910230 | LYME-SPOT IF KIT | Aug 30, 1991 | Substantially Equivalent |
| K910210 | SLIDEX MENINGITE-KIT 5 | Aug 12, 1991 | Substantially Equivalent |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Jul 26, 1991 | Substantially Equivalent |