AQ OPIATES (MORPHINE) TEST— 510(k) K971361
Substantially EquivalentBionike Laboratories, Inc.
FDA 510(k) clearance K971361 for AQ OPIATES (MORPHINE) TEST, Substantially Equivalent on 1997-06-06. Applicant: Bionike Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bionike Laboratories, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code DJG
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