BIONIKE AQ BARBITURATE TEST— 510(k) K990280
Substantially EquivalentBionike, Inc.
FDA 510(k) clearance K990280 for BIONIKE AQ BARBITURATE TEST, Substantially Equivalent on 1999-06-28. Applicant: Bionike, Inc.. Device class: 2.
Clearance details
- Applicant
- Bionike, Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Simi Valley, CA, US
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