Potency Test Strips, Indicator Test Strips
510(k) K974426
Potency Test Strips, Indicator Test Strips is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K974426 on 10 Feb 1999, active as of 10 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 | NumberK974426 | Date10 Feb 1999 | StatusActive |
Official records
- FDA 510(k) database K974426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LIF
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K974426
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Micro-X K100-0105 | K100-0105 / K100-0105 | 00858293006120 | — | On the market |
Similar devices
Other devices filed under FDA product code LIF (Dialyzer Reprocessing System).
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- ULTRAMAX III, DIALYZER REPROCESSING DEVICE by Medicorp, Inc.
- STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS by Environmental Test Systems, Inc.
- DRS 4 ND Dialyzer Reprocessing System by Seratronics, Inc.
- Automatic Dialyzer Reprocessor ADR-22 by Texas Medical Devices, Inc.
- HPR Home Patient Renatron by Renal Systems, Inc.
- Ultramax Dialyzer Reprocessing System by Medicorp, Inc.
- Sterichek Glutaraldehyde Reagent Strips by Hach Company
- ECHO, MODEL MM-1000 by Mesa Medical, Inc.