The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Mi Myoglobin/troponin I Rapid Test.
| Device ID | K022946 |
| 510k Number | K022946 |
| Device Name: | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-04 |
| Decision Date | 2002-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10743816001294 | K022946 | 000 |