The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Cardiac Status Troponin I.
| Device ID | K963513 |
| 510k Number | K963513 |
| Device Name: | CARDIAC STATUS TROPONIN I |
| 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 | 1996-09-03 |
| Decision Date | 1996-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10743816001263 | K963513 | 000 |
| 10743816001256 | K963513 | 000 |
| 10743816001249 | K963513 | 000 |