Company ยท US
Millipore Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2010. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPB | Filter, Infusion Line | 7 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 7 |
| BSN | Filter, Conduction, Anesthetic | 4 |
| JRL | Unit, Filter, Membrane | 3 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 3 |
| FIP | Subsystem, Water Purification | 2 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 |
| DPM | Columns, Liquid Chromatography | 1 |
| FIB | Protector, Transducer, Dialysis | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| JJH | Clinical Sample Concentrator | 1 |
| JZS | Electrophoresis Instrumentation | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
| KPP | Peritoneal Dialysate Filter | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 |
| OMG | Antisera, Fluorescent, Human Metapneumovirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2010 | K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 Millipore Corporation | OMG |
| Apr 1, 2009 | K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT Millipore Corporation | GQL |
| Jan 17, 2003 | K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS Millipore Corp. | BSN |
| Apr 4, 2002 | K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R Millipore Corp. | BSN |
| Jun 10, 1997 | K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) Millipore Corp. | BSN |
| May 27, 1994 | K941326 | ULTRAFREE-CL Millipore Corp. | JJH |
| Apr 21, 1994 | K934069 | MILLEX, DUALEX (PLUS, ULTRA) Millipore Corp. | FIB |
| Dec 11, 1992 | K924347 | WATERS(TM) 996 PDA Millipore Corp. | KIE |
| Sep 11, 1992 | K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE Millipore Corp. | LDM |
| Feb 19, 1992 | K920136 | WATERS 717 AUTOSAMPLER Millipore Corp. | LDM |
| Dec 10, 1991 | K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR Millipore Corp. | KIE |
| Sep 11, 1990 | K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE Millipore Corp. | LDM |
| Jul 31, 1987 | K872792 | WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM Millipore Corp. | |
| Jul 16, 1987 | K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM Millipore Corp. | LDM |
| Apr 22, 1987 | K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM Millipore Corp. | LDM |
| Jan 9, 1987 | K864267 | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) Millipore Corp. | DPM |
| Jul 29, 1986 | K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR Millipore Corp. | KIE |
| Mar 6, 1985 | K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR Millipore Corp. | LDM |
| Mar 5, 1985 | K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D Millipore Corp. | LDM |
| Jul 6, 1984 | K841403 | HEMO-RO WATER PURIFICATION SYS Millipore Corp. | FIP |
| Oct 4, 1983 | K832952 | MILLIPORE IVEX INT FILTER UNIT Millipore Corp. | FPB |
| Jul 13, 1981 | K811432 | MILLIPORE DUAL RATE INTRAVENOUS CASSETTE Millipore Corp. | LDR |
| Mar 13, 1981 | K803275 | KPP PERITONEAL DIALYSATE FILTER Millipore Corp. | KPP |
| Aug 20, 1980 | K801500 | ULTRAFREE CALCIUM FILTER Millipore Corp. | JRL |
| Jun 28, 1979 | K790445 | ULTRA-FREE Millipore Corp. | JRL |
| Sep 15, 1978 | K781043 | CEA-IMMERSIBLE SEPARATOR Millipore Corp. | JRL |
| Jun 28, 1978 | K780352 | IMMUNOZYME TOXOPLASMA ANTIBODY Millipore Corp. | GLZ |
| Apr 19, 1978 | K780114 | IMMUNOZYME E. HISTOLYTICA ANTIGENS Millipore Corp. | |
| Jan 24, 1978 | K772236 | FILTER, PERITONEAL DIALY. ADMIN. SET Millipore Corp. | KDJ |
| Oct 4, 1977 | K771763 | HEMO-RO Millipore Corp. | FIP |
| Jun 14, 1977 | K770703 | FILTER UNIT, SINGLE USE Millipore Corp. | FPB |
| Feb 1, 1977 | K770150 | ELECTRO IMMUNO ASSAY KIT Millipore Corp. | JZS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2010 | Millipore Corporation Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS. Terminated |
BSN | K023892 |
| Mar 6, 2009 | Millipore Corporation LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit. Terminated |
GNW | K974302 |
| Mar 6, 2009 | Millipore Corporation LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit
Immunofluorescence Assay
Cat. No. 3121
FOR IN VITRO DIAGNOSTIC USE
Authorized Representative:
Millipore (UK) Ltd.
Fleming Road,
Kirkton Campus
L Terminated |
GNW | K974302 |
| Jul 20, 2004 | Millipore Corp. Millex HA Syringe Filter 0.45um, Sterile
Catalog Number: SLHA033SS Terminated |
FPB | None listed |
| Jul 20, 2004 | Millipore Corp. Millex GS- Syringe Filter 0.22um, Sterile
Catalog Number: SLGS033SS Terminated |
FPB | None listed |
| Jul 20, 2004 | Millipore Corp. Millex-AA Syringe Driven Filter 0.8 um, Sterile
Catalog Number: SLAAM33SS Terminated |
FPB | None listed |
| Jul 20, 2004 | Millipore Corp. Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile
Catalog Number: SLHAM33SS Terminated |
FPB | None listed |
| Jul 20, 2004 | Millipore Corp. Millex-GS Syringe Filter Unit 0.22 um, Sterile
Catalog Number: SLGSM33SS Terminated |
FPB | None listed |