FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
K Number: K873577
·
Decision Apr 28, 1988
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
3
Review Days
238
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Basic Information
- Device Name
- GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
- K Number
- K873577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diamond Sensor Systems
- Date Received
- September 3, 1987
- Decision Date
- April 28, 1988
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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