FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IMMUNOZYME E. HISTOLYTICA ANTIGENS
K Number: K780114
·
Decision Apr 19, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
30
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IMMUNOZYME E. HISTOLYTICA ANTIGENS
- K Number
- K780114
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Millipore Corp.
- Date Received
- January 23, 1978
- Decision Date
- April 19, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
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 |