The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Shot-gun Isolat Proced/measurement Ck-mb In Serum.
| Device ID | K874284 |
| 510k Number | K874284 |
| Device Name: | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | Noel Richard |
| Correspondent | Noel Richard DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-14 |
| Decision Date | 1988-01-21 |