STREPTOCOCCUS PNEUMONIAE CONTROL— 510(k) K840512
Substantially EquivalentScientific Device Laboratory, Inc.
FDA 510(k) clearance K840512 for STREPTOCOCCUS PNEUMONIAE CONTROL, Substantially Equivalent on 1984-03-23. Applicant: Scientific Device Laboratory, Inc..
Clearance details
- Applicant
- Scientific Device Laboratory, Inc.
- Product code
- Code GTY
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code GTY
product code GTY- Death
- 2
- Total
- 2
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.