Atlas FDA

AVL 9110PH ANALYZER

FDA 510(k) clearance K932642 · decided 1993-10-14

Clearance details

K-number
K932642
Device name
AVL 9110PH ANALYZER
Applicant
Avl Scientific Corp.
Decision
Substantially Equivalent
Date received
1993-06-02
Decision date
1993-10-14
Days to decision
134 days
Clearance type
Traditional
Product code
CHL
Device class
2
Regulation number
862.1120
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Roswell, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled a recall (Z-0605-05)Roche Diagnostics Corp.2005-03-11
Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled a recall (Z-0606-05)Roche Diagnostics Corp.2005-03-11
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled a recall (Z-0607-05)Roche Diagnostics Corp.2005-03-11
Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the o recall (Z-0608-05)Roche Diagnostics Corp.2005-03-11
Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III ele recall (Z-0609-05)Roche Diagnostics Corp.2005-03-11
AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 elect recall (Z-0610-05)Roche Diagnostics Corp.2005-03-11
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007 recall (Z-0611-05)Roche Diagnostics Corp.2005-03-11