Hr Vacutrac
510(k) K881201
Hr Vacutrac is a medical device (FDA Class II; FDA product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection) made by ICU Medical, Inc., cleared under FDA 510(k) K881201 on 16 May 1988, active as of 22 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 | NumberK881201 | Date16 May 1988 | StatusActive |
Official records
- FDA 510(k) database K881201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JKA
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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