FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POCKETCHEM UA AUTION STICKS 10TA
K Number: K022386
·
Decision Sep 17, 2002
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
18
Review Days
57
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Basic Information
- Device Name
- POCKETCHEM UA AUTION STICKS 10TA
- K Number
- K022386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arkray, Inc.
- Date Received
- July 22, 2002
- Decision Date
- September 17, 2002
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K200788 | Assure Titanium Blood Glucose Monitoring System | May 23, 2022 | Substantially Equivalent |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Oct 7, 2016 | Substantially Equivalent |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Feb 1, 2013 | Substantially Equivalent |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Dec 23, 2009 | Substantially Equivalent |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Mar 24, 2006 | Substantially Equivalent |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Jan 31, 2006 | Substantially Equivalent |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Jun 17, 2005 | Substantially Equivalent |