RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
FDA 510(k) clearance K030211 · decided 2003-06-13
Clearance details
- K-number
- K030211
- Device name
- RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
- Applicant
- Icn Biomedicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-21
- Decision date
- 2003-06-13
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- DKX
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Burlingame, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (K800364) | Hoffrel Instruments, Inc. | 1980-03-12 |
Recalls involving this device
No recalls on record reference this clearance.