FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL
K Number: K792377
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
15
Review Days
305
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Basic Information
- Device Name
- CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL
- K Number
- K792377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Environmental Chemical Specialties
- Date Received
- November 26, 1979
- Decision Date
- September 26, 1980
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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Other Clearances by Environmental Chemical Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K812635 | ANEMIA CONTROL | Oct 2, 1981 | Substantially Equivalent |
| K811810 | URIC ACID TEST | Jul 15, 1981 | Substantially Equivalent |
| K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II | Jul 10, 1981 | Substantially Equivalent |
| K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II | Jul 10, 1981 | Substantially Equivalent |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Jan 2, 1981 | Substantially Equivalent |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | Sep 16, 1980 | Substantially Equivalent |
| K801061 | TOTAL PROTEIN TEST | Jul 21, 1980 | Substantially Equivalent |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Dec 6, 1979 | Substantially Equivalent |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Dec 6, 1979 | Substantially Equivalent |
| K792375 | ELEVATED LIPID CONTROL | Dec 6, 1979 | Substantially Equivalent |