The following data is part of a premarket notification filed by Serapine Corp. with the FDA for Shot Gun Kit For Ck-mb.
| Device ID | K831391 |
| 510k Number | K831391 |
| Device Name: | SHOT GUN KIT FOR CK-MB |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| Applicant | SERAPINE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-29 |
| Decision Date | 1983-11-04 |