Bartels Extracellular Matrix
510(k) K902726
Bartels Extracellular Matrix is a Class I device made by Baxter Healthcare Corp, cleared under FDA 510(k) K902726 on 24 Sep 1990, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902726 | Date24 Sep 1990 | StatusActive |
Official records
- FDA 510(k) database K902726
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIR
- Device class
- Class I
- Regulation
- 21 CFR Part 864.2280
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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