FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRAFREE CALCIUM FILTER
K Number: K801500
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
8
Applicant Total
30
Review Days
54
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Basic Information
- Device Name
- ULTRAFREE CALCIUM FILTER
- K Number
- K801500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Millipore Corp.
- Date Received
- June 27, 1980
- Decision Date
- August 20, 1980
- Product Code
- JRL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JRL | Unit, Filter, Membrane | FDA class 1 | Clinical Chemistry |
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Other Clearances by Millipore Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Jan 17, 2003 | Substantially Equivalent |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | Apr 4, 2002 | Substantially Equivalent |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Jun 10, 1997 | Substantially Equivalent |
| K941326 | ULTRAFREE-CL | May 27, 1994 | Substantially Equivalent |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Apr 21, 1994 | Substantially Equivalent |
| K924347 | WATERS(TM) 996 PDA | Dec 11, 1992 | Substantially Equivalent |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Sep 11, 1992 | Substantially Equivalent |
| K920136 | WATERS 717 AUTOSAMPLER | Feb 19, 1992 | Substantially Equivalent |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Dec 10, 1991 | Substantially Equivalent |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Sep 11, 1990 | Substantially Equivalent |