The following data is part of a premarket notification filed by Methodist Hospital Of Memphis with the FDA for Replacement Reagents For Smac Ii Systems.
| Device ID | K852306 |
| 510k Number | K852306 |
| Device Name: | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS |
| Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Applicant | METHODIST HOSPITAL OF MEMPHIS 1265 UNION AVE. Memphis, TN 38104 |
| Contact | Von Boeckman |
| Correspondent | Von Boeckman METHODIST HOSPITAL OF MEMPHIS 1265 UNION AVE. Memphis, TN 38104 |
| Product Code | JJC |
| CFR Regulation Number | 862.2150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-08-02 |