Paramax Iron Reagent
510(k) K881104
Paramax Iron Reagent is a Class I device made by Baxter Healthcare Corp, cleared under FDA 510(k) K881104 on 28 Apr 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 | NumberK881104 | Date28 Apr 1988 | StatusActive |
Official records
- FDA 510(k) database K881104
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JIY
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1410
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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- IRON PROCEDURE by Data Medical Associates, Inc.