K822248 is an FDA 510(k) clearance for the DESERET ARTERIAL BLOOD SAMPLING KIT. This device is classified as a Arterial Blood Sampling Kit (Class I - General Controls, product code CBT).
Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1982, 84 days after receiving the submission on July 29, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1100. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..
| 510(k) Number | K822248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1982 |
| Decision Date | October 21, 1982 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBT — Arterial Blood Sampling Kit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1100 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |