K871198 is an FDA 510(k) clearance for the BONE MARROW COLLECTION KIT AND STAND. This device is classified as a Bone Marrow Collection/transfusion Kit (Class II - Special Controls, product code LWE).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 6, 1987, 227 days after receiving the submission on March 24, 1987.
This device falls under the General Hospital FDA review panel. 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 | K871198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1987 |
| Decision Date | November 06, 1987 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LWE — Bone Marrow Collection/transfusion Kit |
| Device Class | Class II - Special Controls |
| 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. |