The following data is part of a premarket notification filed by Gemini, Inc. with the FDA for Gemeni Ck-mb Isoenzyme Abnormal Serum.
| Device ID | K810870 |
| 510k Number | K810870 |
| Device Name: | GEMENI CK-MB ISOENZYME ABNORMAL SERUM |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | GEMINI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-31 |
| Decision Date | 1981-04-14 |