The following data is part of a premarket notification filed by American Dade with the FDA for Stratus(r) Ck-mb Fluorometric Enzyme Immunoassay.
Device ID | K873171 |
510k Number | K873171 |
Device Name: | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY |
Classification | Fluorometric Method, Cpk Or Isoenzymes |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | JHX |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-09-29 |