FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRACK VALPROIC ACID TEST CARTRIDGE
K Number: K934061
·
Decision Dec 29, 1993
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
16
Review Days
132
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Basic Information
- Device Name
- BIOTRACK VALPROIC ACID TEST CARTRIDGE
- K Number
- K934061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biotrack, Inc.
- Date Received
- August 19, 1993
- Decision Date
- December 29, 1993
- Product Code
- LEG
- 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 |
|---|---|---|---|
| LEG | Enzyme Immunoassay, Valproic Acid | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEG), ordered by most recent decision date.
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
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ONLINE VALPROIC ACID
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VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
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ROCHE ONLINE TDM VALPROIC ACID
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SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
FDA 510(k)
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Other Clearances by Biotrack, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS | Dec 29, 1993 | Substantially Equivalent |
| K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL | Aug 5, 1992 | Substantially Equivalent |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Sep 17, 1990 | Substantially Equivalent |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | May 30, 1990 | Substantially Equivalent |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | Feb 23, 1990 | Substantially Equivalent |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Oct 10, 1989 | Substantially Equivalent |
| K895102 | BIOTRACK PDS MONITOR | Oct 10, 1989 | Substantially Equivalent |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Oct 6, 1989 | Substantially Equivalent |