The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Rapid Barbiturate Test Strip And Test Card, Models 7015 And 7016.
| Device ID | K030211 |
| 510k Number | K030211 |
| Device Name: | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 |
| Classification | Thin Layer Chromatography, Barbiturate |
| Applicant | ICN BIOMEDICALS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Contact | Charkes C.f. Yu |
| Correspondent | Charkes C.f. Yu ICN BIOMEDICALS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Product Code | DKX |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-06-13 |
| Summary: | summary |