FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QMS TM- PHENYTOIN
K Number: K904815
·
Decision Nov 6, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
43
Applicant Total
28
Review Days
13
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Basic Information
- Device Name
- QMS TM- PHENYTOIN
- K Number
- K904815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Seradyn, Inc.
- Date Received
- October 24, 1990
- Decision Date
- November 6, 1990
- Product Code
- DIP
- 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 |
|---|---|---|---|
| DIP | Enzyme Immunoassay, Diphenylhydantoin | FDA class 2 | Clinical Toxicology |
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FDA Class 2
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| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Nov 3, 2004 | Substantially Equivalent |