FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK CEPT
K Number: K801668
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
37
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- QUICK CEPT
- K Number
- K801668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Diagnostics Co., Inc.
- Date Received
- July 21, 1980
- Decision Date
- August 13, 1980
- Product Code
- JHS
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by Laboratory Diagnostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K761232 | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD | Dec 21, 1976 | Substantially Equivalent |