FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUALITY CONTROL MATERIAL (ASSAYED)
K Number: K935819
·
Decision Mar 22, 1994
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
10
Applicant Total
2
Review Days
109
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Basic Information
- Device Name
- QUALITY CONTROL MATERIAL (ASSAYED)
- K Number
- K935819
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Columbia Diagnostics, Inc.
- Date Received
- December 3, 1993
- Decision Date
- March 22, 1994
- Product Code
- DKC
- 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 |
|---|---|---|---|
| DKC | Alcohol Control Materials | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKC), ordered by most recent decision date.
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Other Clearances by Columbia Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854119 | ACCURACY | Oct 25, 1985 | Substantially Equivalent |