The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Ammonia/alcohol Control Set.
| Device ID | K070504 |
| 510k Number | K070504 |
| Device Name: | AMMONIA/ALCOHOL CONTROL SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010070 | K070504 | 000 |