The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Carbon Dioxide Liquid Reagent.
| Device ID | K012332 |
| 510k Number | K012332 |
| Device Name: | JAS CARBON DIOXIDE LIQUID REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010698 | K012332 | 000 |