FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K Number: K880353
·
Decision Jun 15, 1988
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
125
Review Days
141
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Basic Information
- Device Name
- CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
- K Number
- K880353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ciba Corning Diagnostics Corp.
- Date Received
- January 26, 1988
- Decision Date
- June 15, 1988
- Product Code
- GKR
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Jul 26, 1996 | Substantially Equivalent |
| K961657 | CIBA CORNING 400 SYSTEM | Jun 25, 1996 | Substantially Equivalent |
| K962021 | CIBA CORNING 348 SYSTEM | Jun 24, 1996 | Substantially Equivalent |
| K962126 | ACS CKMB II IMMUNOASSAY | Jun 21, 1996 | Substantially Equivalent |
| K962041 | ACS LH2 IMMUNOASSAY | Jun 21, 1996 | Substantially Equivalent |
| K961510 | ACS FRT4 IMMUNOASSAY | Jun 17, 1996 | Substantially Equivalent |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Apr 23, 1996 | Substantially Equivalent |
| K955873 | ACS PHENYTOIN ASSAY | Mar 11, 1996 | Substantially Equivalent |