DKX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Thin Layer Chromatography, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (K030211) | Icn Biomedicals, Inc. | 2003-06-13 |
| ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (K800364) | Hoffrel Instruments, Inc. | 1980-03-12 |
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Every clearance here is in the API, with alerts when new ones post.