RESUBMISSION OF THE KLEERZIT REAGENT— 510(k) K864866
Substantially EquivalentAdvanced Biomedical Methods, Inc.
FDA 510(k) clearance K864866 for RESUBMISSION OF THE KLEERZIT REAGENT, Substantially Equivalent on 1987-03-16. Applicant: Advanced Biomedical Methods, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Biomedical Methods, Inc.
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Niles, IL, US
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More clearances from Advanced Biomedical Methods, Inc.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.