The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for (modified Version) Integra Ion Selective Electrode (ise) Module.
| Device ID | K963627 |
| 510k Number | K963627 |
| Device Name: | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-11 |
| Decision Date | 1996-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630915095 | K963627 | 000 |
| 04015630915088 | K963627 | 000 |
| 04015630915071 | K963627 | 000 |
| 04015630915040 | K963627 | 000 |
| 04015630915033 | K963627 | 000 |
| 04015630908684 | K963627 | 000 |
| 04015630908677 | K963627 | 000 |
| 04015630032440 | K963627 | 000 |