The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Bicarb Ph Reagent Strips.
| Device ID | K031267 |
| 510k Number | K031267 |
| Device Name: | STERICHEK BICARB PH REAGENT STRIPS |
| Classification | Strip, Dialysate Ph Indicator |
| Applicant | ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD. 106 Elkhart, IN 46514 |
| Contact | David A Morris |
| Correspondent | David A Morris ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD. 106 Elkhart, IN 46514 |
| Product Code | MNV |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851575007143 | K031267 | 000 |