FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANCOMYCIN FLEX REAGENT CARTRIDGE
K Number: K963267
·
Decision Sep 13, 1996
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
30
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VANCOMYCIN FLEX REAGENT CARTRIDGE
- K Number
- K963267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Intl., Inc.
- Date Received
- August 20, 1996
- Decision Date
- September 13, 1996
- Product Code
- LEH
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEH), ordered by most recent decision date.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONLINE TDM Vancomycin Gen.3
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IVANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Dade Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974343 | DADE INNOVIN | Jul 22, 1998 | Substantially Equivalent |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | Nov 17, 1997 | Substantially Equivalent |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Nov 6, 1997 | Substantially Equivalent |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | Oct 20, 1997 | Substantially Equivalent |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Sep 8, 1997 | Substantially Equivalent |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Aug 15, 1997 | Substantially Equivalent |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | Jul 7, 1997 | Substantially Equivalent |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Jun 4, 1997 | Substantially Equivalent |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | May 2, 1997 | Substantially Equivalent |
| K964715 | PARAMAX SALICYLATE REAGENT | Apr 25, 1997 | Substantially Equivalent |