DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG— 510(k) K792282
Substantially EquivalentCalifornia Medical Developments, Inc.
FDA 510(k) clearance K792282 for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG, Substantially Equivalent on 1980-02-29. Applicant: California Medical Developments, Inc.. Device class: 2.
Clearance details
- Applicant
- California Medical Developments, Inc.
- Product code
- Code DKE
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.