STERICHEK BICARB PH REAGENT STRIPS
FDA 510(k) clearance K031267 · decided 2003-12-23
Clearance details
- K-number
- K031267
- Device name
- STERICHEK BICARB PH REAGENT STRIPS
- Applicant
- Environmental Test Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-21
- Decision date
- 2003-12-23
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- MNV
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) | Reprocessing Products Corp | 2011-01-07 |
| MITEK MINI ANCHOR (K936311) | Mitek Surgical Products, Inc. | 1995-10-31 |
| MITEK ABSORBABLE ANCHOR (K941599) | Mitek Surgical Products, Inc. | 1995-10-24 |
| ABSORBALBE ANCHOR (K944051) | Mitek Surgical Products, Inc. | 1995-08-02 |
| SERIM(TM) BICARB PH REAGENT STRIPS (K945491) | Serim Research Corp. | 1995-02-01 |
Recalls involving this device
No recalls on record reference this clearance.