The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Chromatography Clinical Use 75jqr.
Device ID | K914841 |
510k Number | K914841 |
Device Name: | CHROMATOGRAPHY CLINICAL USE 75JQR |
Classification | Apparatus, 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 | KIE |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-25 |
Decision Date | 1991-12-10 |