The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-mb/myoglobin.
| Device ID | K952360 |
| 510k Number | K952360 |
| Device Name: | CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-08-14 |