510(k) K030211
- Device
- RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
- Applicant
- ICN BIOMEDICALS, INC.
- 510(k) number
- K030211
- Product code
- DKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-13
- Date received
- 2003-01-21
- Regulation
- 862.3150
- Classification name
- Thin Layer Chromatography, Barbiturate
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARKES C.F. YU
- Address
- 1429 Rollins Rd. Burlingame CA US 94010 94010
FDA Registration Numbers#
- 3005984081
Source Documents#
Other 510(k) Records For Product Code DKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K800364 | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | Hoffrel Instruments, Inc. | 1980-03-12 |
Legacy Summary#
summary
FDA Review#
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