Electrode A.Ph Blood Gas B.Electrolyte Systems
FDA 510(k) K884267 · Alko Diagnostic Corp.
510(k) numberK884267
Submission
- Device name
- Electrode A.Ph Blood Gas B.Electrolyte Systems
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- October 11, 1988
- Decision date
- May 4, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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Questions and answers
When was Electrode A.Ph Blood Gas B.Electrolyte Systems cleared by the FDA?
Electrode A.Ph Blood Gas B.Electrolyte Systems (K884267) received a 510(k) decision of Substantially Equivalent on May 4, 1989, 205 days after the submission was received.
What is the product code of K884267?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.