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 |