FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K Number: K901538
·
Decision Jun 26, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
35
Review Days
85
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Basic Information
- Device Name
- MODIFIED OPUS VALPROIC ACID TEST SYSTEM
- K Number
- K901538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Pb Diagnostic Systems, Inc.
- Date Received
- April 2, 1990
- Decision Date
- June 26, 1990
- 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
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONLINE VALPROIC ACID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVIA IMS VALPROIC ACID METHOD
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FDA Class 2
·Clinical Toxicology
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE ONLINE TDM VALPROIC ACID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Pb Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | Jul 28, 1994 | Substantially Equivalent |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Jul 20, 1994 | Substantially Equivalent |
| K933389 | OPUS CMV-G | Jun 28, 1994 | Substantially Equivalent |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Mar 7, 1994 | Substantially Equivalent |
| K935229 | OPUS DIGITOXIN | Dec 22, 1993 | Substantially Equivalent |
| K934705 | OPUS NAPA | Nov 22, 1993 | Substantially Equivalent |
| K933675 | OPUS TOTAL CK | Sep 8, 1993 | Substantially Equivalent |
| K933066 | OPUS ESTRADIOL | Sep 8, 1993 | Substantially Equivalent |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | Jul 8, 1993 | Substantially Equivalent |
| K926131 | OPUS MAGNUM ANALYZER | Jun 7, 1993 | Substantially Equivalent |