BIOSTARS STREP A OIA -- MODIFICATION— 510(k) K922765
Substantially EquivalentBiosearch Medical Products, Inc.
FDA 510(k) clearance K922765 for BIOSTARS STREP A OIA -- MODIFICATION, Substantially Equivalent on 1992-08-20. Applicant: Biosearch Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Biosearch Medical Products, Inc.
- Product code
- Code GTY
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
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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.