The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Waters(tm) Lc Module I For Clinical Use.
| Device ID | K922388 |
| 510k Number | K922388 |
| Device Name: | WATERS(TM) LC MODULE I FOR CLINICAL USE |
| Classification | Instrumentation, High Pressure Liquid Chromatography |
| Applicant | MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
| Contact | Marquand S Ransom |
| Correspondent | Marquand S Ransom MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
| Product Code | LDM |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-09-11 |