STANBIO ACETAMINOPHEN TEST SET #0850— 510(k) K801014
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K801014 for STANBIO ACETAMINOPHEN TEST SET #0850, Substantially Equivalent on 1980-06-20. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code LDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3030
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code LDP
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- K050283 — CREATININE LIQUICOLOR
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Adverse events under product code LDP
product code LDP- Other
- 1
- Total
- 1
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.