The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus (r) Cs Myoglobin (myo) Testpak.
| Device ID | K984065 |
| 510k Number | K984065 |
| Device Name: | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1998-12-14 |
| Summary: | summary |