FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMES TDA VALPROIC ACID TEST
K Number: K830789
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
158
Review Days
29
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Basic Information
- Device Name
- AMES TDA VALPROIC ACID TEST
- K Number
- K830789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Miles Laboratories, Inc.
- Date Received
- March 14, 1983
- Decision Date
- April 12, 1983
- Product Code
- LEG
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| 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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ADVIA IMS VALPROIC ACID METHOD
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VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
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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 Miles Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 | Substantially Equivalent |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Apr 28, 1988 | Substantially Equivalent |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Apr 5, 1988 | Substantially Equivalent |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Dec 22, 1987 | Substantially Equivalent |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Oct 28, 1987 | Substantially Equivalent |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |