Modified Paramax Glucose Reagent
510(k) K873936
Modified Paramax Glucose Reagent is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K873936 on 23 Nov 1987, 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 | NumberK873936 | Date23 Nov 1987 | StatusActive |
Official records
- FDA 510(k) database K873936
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CFR
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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- ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 by Siemens Healthcare Diagnostics
- SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P by Sigma Diagnostics, Inc.
- ULTRA-VIOLET GLUCOSE REAGENT KIT by Biochemical Trade, Inc.