RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips, Model K100-0104
FDA 510(k) K101750 · Reprocessing Products Corp
510(k) numberK101750
Submission
- Device name
- RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips, Model K100-0104
- Applicant
- Reprocessing Products Corp
Maple Grove, MN, US - Received
- June 22, 2010
- Decision date
- January 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNV – Strip, Dialysate Ph Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MNV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031267 | Sterichek Bicarb PH Reagent StripsMNV · Traditional | Environmental Test Systems, Inc. | 12/23/2003SE |
| K936311 | Mitek Mini AnchorMNV · Traditional | Mitek Surgical Products, Inc. | 10/31/1995SN |
| K941599 | Mitek Absorbable AnchorMNV · Traditional | Mitek Surgical Products, Inc. | 10/24/1995SN |
| K944051 | Absorbalbe AnchorMNV · Traditional | Mitek Surgical Products, Inc. | 08/02/1995SE |
| K945491 | Serim(Tm) Bicarb PH Reagent StripsMNV · Traditional | Serim Research Corp. | 02/01/1995SE |
More from Serim Research Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K123805 | E-Z Chek Blood Leak Test StripsFJD · Traditional | 03/20/2013SE |
| K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineMSY · Traditional | 05/08/2009SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | 02/10/1999SE |
| K974064 | Micro X Residual Test StripsMSY · Traditional | 12/07/1998SE |
| K950602 | Port Caps (Protective Closures Foe Reprocessed HemodialyzersFJI · Traditional | 11/30/1995SE |
Questions and answers
When was RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips, Model K100-0104 cleared by the FDA?
RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips, Model K100-0104 (K101750) received a 510(k) decision of Substantially Equivalent on January 7, 2011, 199 days after the submission was received.
What is the product code of K101750?
The FDA product code is MNV – Strip, Dialysate Ph Indicator, a Class II (moderate risk) device regulated under 21 CFR 876.5820.