510(k) K945491
- Device
- SERIM(TM) BICARB PH REAGENT STRIPS
- Applicant
- SERIM RESEARCH CORP.
- 510(k) number
- K945491
- Product code
- MNV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-01
- Date received
- 1994-11-08
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT C BOGUSLASKI
- Address
- P.O. Box 4002 Elkhart IN US 46514 46514
FDA Registration Numbers#
- 1833387
- 2028411
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | Environmental Test Systems, Inc. | 2003-12-23 |
| 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 |
Legacy Summary#
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FDA Review#
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