The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Aia-pack Ck-mb.
| Device ID | K913298 |
| 510k Number | K913298 |
| Device Name: | AIA-PACK CK-MB |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1991-09-27 |