The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Modification To Cardiac Status Ck-mb/myoglobin Rapid One-step Test, Lifesign Mi Ck-mb/myoglobin, Lifesign Ck-mb/myoglobi.
| Device ID | K991299 |
| 510k Number | K991299 |
| Device Name: | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| 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 | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-06 |
| Decision Date | 1999-05-28 |