The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Ise Diluent, 1n Kcl, Internal Reference And Ise Standards Low And High.
| Device ID | K051646 |
| 510k Number | K051646 |
| Device Name: | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-21 |
| Decision Date | 2005-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014757 | K051646 | 000 |
| 00811727012845 | K051646 | 000 |
| 00811727012838 | K051646 | 000 |
| 00811727012821 | K051646 | 000 |
| 00811727012722 | K051646 | 000 |
| 00811727012432 | K051646 | 000 |
| 00811727012425 | K051646 | 000 |
| 00811727012418 | K051646 | 000 |
| 00811727012401 | K051646 | 000 |