FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELFIA PLATE FLUOROMETER 1232
K Number: K895240
·
Decision Oct 4, 1989
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
129
Review Days
44
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Basic Information
- Device Name
- DELFIA PLATE FLUOROMETER 1232
- K Number
- K895240
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- August 21, 1989
- Decision Date
- October 4, 1989
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Jun 30, 1997 | Substantially Equivalent |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |