FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICA-OF EMIT AED PRIMIDONE ASSAY
K Number: K832798
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
448
Review Days
57
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Basic Information
- Device Name
- MODIFICA-OF EMIT AED PRIMIDONE ASSAY
- K Number
- K832798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3680
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Syva Co.
- Date Received
- August 18, 1983
- Decision Date
- October 14, 1983
- Product Code
- DJD
- 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 |
|---|---|---|---|
| DJD | Enzyme Immunoassay, Primidone | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by Syva Co.
| K Number | Device Name | ||
|---|---|---|---|
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | Aug 13, 2001 | Substantially Equivalent |
| K012257 | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 | Aug 3, 2001 | Substantially Equivalent |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Jul 2, 2001 | Substantially Equivalent |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Jun 6, 2001 | Substantially Equivalent |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | May 17, 2001 | Substantially Equivalent |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | Feb 1, 2000 | Substantially Equivalent |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Feb 1, 2000 | Substantially Equivalent |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Jan 27, 2000 | Substantially Equivalent |
| K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL | Jan 27, 2000 | Substantially Equivalent |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | Jan 27, 2000 | Substantially Equivalent |