FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPENSER ASPIRATOR DA 300
K Number: K812782
·
Decision Oct 23, 1981
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
129
Review Days
18
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Basic Information
- Device Name
- DISPENSER ASPIRATOR DA 300
- K Number
- K812782
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- October 5, 1981
- Decision Date
- October 23, 1981
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
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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 |