i-STAT CG4+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc. · Clinical Chemistry
Open FDA's page for this record- Third party flag
- N
- City
- Princton
- Advisory committee description
- Clinical Chemistry
- Address 1
- 400 College Rd. E.
- Statement or summary
- Summary
- Product code
- CHL
- Zip code
- 08540
- Applicant
- Abbott Point of Care, Inc.
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- US
- Device name
- i-STAT CG4+ cartridge with the i-STAT 1 System
- Advisory committee
- CH
- Contact
- Brian Ma
- K number
- K244014
- State
- NJ
- Date received
- 2024-12-26
- Review advisory committee
- CH
- Postal code
- 08540
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1120
- Device class
- 2
- Registration number
- 1181121, 1000455123, 3037000637, 3005643513, 1219029, 1217183, 3007662974, 3002637618, 1717966, 3012817228, 1036362, 3006198300, 1220972, 1222035, 3015997711, 2432235, 8030478, 1220649, 9610633, 3004102403, 3007490412, 2050012, 3012104670, 3023162659, 2245578, 3003795116, 3004959793, 3013513377, 3014506106, 3003971136, 1219913, 2431530, 9610126, 3002807968
- FEI number
- 1181121, 1000455123, 3037000637, 3005643513, 1219029, 1217183, 3007662974, 3001576181, 3002637618, 1717966, 3012817228, 1036362, 3006198300, 1220972, 3002806559, 1222035, 3015997711, 2432235, 1220649, 3004102403, 3007490412, 2050012, 3023162659, 3002806693, 2245578, 3003795116, 3004959793, 3013513377, 3014506106, 3003971136, 1219913, 2431530, 3012104670, 3002807968