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 |