510(k) K031267
- Device
- STERICHEK BICARB PH REAGENT STRIPS
- Applicant
- ENVIRONMENTAL TEST SYSTEMS, INC.
- 510(k) number
- K031267
- Product code
- MNV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-23
- Date received
- 2003-04-21
- Regulation
- 876.5820
- Classification name
- Strip, Dialysate Ph Indicator
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A MORRIS
- Address
- 23575 County Rd. 106 Elkhart IN US 46514 46514
FDA Registration Numbers#
- 1833387
- 2028411
Source Documents#
Other 510(k) Records For Product Code MNV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101750 | 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 | Reprocessing Products Corp | 2011-01-07 |
| K936311 | MITEK MINI ANCHOR | Mitek Surgical Products, Inc. | 1995-10-31 |
| K941599 | MITEK ABSORBABLE ANCHOR | Mitek Surgical Products, Inc. | 1995-10-24 |
| K944051 | ABSORBALBE ANCHOR | Mitek Surgical Products, Inc. | 1995-08-02 |
| K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | Serim Research Corp. | 1995-02-01 |
Legacy Summary#
summary
FDA Review#
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