The following data is part of a premarket notification filed by Access Bio Incorporate with the FDA for Carestart Cardiac 3-in-1 Troponin 1/ck-mb/myoglobin.
| Device ID | K051925 |
| 510k Number | K051925 |
| Device Name: | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H Monmouth Jct., NJ 08852 |
| Contact | Young Ho Choi |
| Correspondent | Young Ho Choi ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H Monmouth Jct., NJ 08852 |
| Product Code | MMI |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-11-29 |