The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Troponin I Test.
| Device ID | K042227 |
| 510k Number | K042227 |
| Device Name: | INSTANT-VIEW TROPONIN I TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-11-19 |
| Summary: | summary |