FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD GAS SYSTEM MODEL 168
K Number: K781968
·
Decision Jan 3, 1979
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
111
Review Days
40
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BLOOD GAS SYSTEM MODEL 168
- K Number
- K781968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- November 24, 1978
- Decision Date
- January 3, 1979
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHL), ordered by most recent decision date.
ABL90 FLEX PLUS System, safeCLINITUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG4+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G3+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Corning Medical & Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Jan 12, 1988 | Substantially Equivalent |
| K872273 | CORNING EASY WASH ELISA PLATES | Jul 7, 1987 | Substantially Equivalent |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | Jun 15, 1987 | Substantially Equivalent |
| K863789 | CORNING ELISA PLATES | Oct 3, 1986 | Substantially Equivalent |
| K854024 | CORNING MAGIC MAB HCG RADIOIMMUNOASSAY | Nov 26, 1985 | Substantially Equivalent |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | Sep 16, 1985 | Substantially Equivalent |
| K851939 | CORNING CERTAIN -ISE | Jun 14, 1985 | Substantially Equivalent |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Jun 13, 1985 | Substantially Equivalent |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Mar 25, 1985 | Substantially Equivalent |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Mar 12, 1985 | Substantially Equivalent |