The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Carbon Dioxide Liquid Stable Reagent.
| Device ID | K070251 |
| 510k Number | K070251 |
| Device Name: | CARBON DIOXIDE LIQUID STABLE REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | William F Walters, Jr |
| Correspondent | William F Walters, Jr POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2007-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014979 | K070251 | 000 |
| 00811727016102 | K070251 | 000 |
| 00811727010667 | K070251 | 000 |
| 00811727010674 | K070251 | 000 |
| 00811727010681 | K070251 | 000 |
| 00811727012616 | K070251 | 000 |
| 00811727012623 | K070251 | 000 |
| 00811727012630 | K070251 | 000 |
| 00811727013453 | K070251 | 000 |
| 00811727015792 | K070251 | 000 |