FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
K Number: K934124
·
Decision Apr 13, 1994
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
16
Review Days
231
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Basic Information
- Device Name
- AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
- K Number
- K934124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andronic Devices, Ltd.
- Date Received
- August 25, 1993
- Decision Date
- April 13, 1994
- Product Code
- JQW
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K935381 | KAPS POSITIONING ARM | Apr 15, 1994 | Substantially Equivalent |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Mar 31, 1994 | Substantially Equivalent |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Feb 3, 1994 | Substantially Equivalent |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Oct 19, 1992 | Substantially Equivalent |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 2, 1991 | Substantially Equivalent |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Aug 2, 1991 | Substantially Equivalent |