K930986 is an FDA 510(k) clearance for the BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560. This device is classified as a Arterial Blood Sampling Kit (Class I - General Controls, product code CBT).
Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on July 14, 1993, 139 days after receiving the submission on February 25, 1993.
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 | K930986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | February 25, 1993 |
| Decision Date | July 14, 1993 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| 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. |