MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON— 510(k) K972669
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K972669 for MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON, Substantially Equivalent on 1998-01-22. Applicant: Polymer Technology Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.