The following data is part of a premarket notification filed by Murex Diagnostics, Inc. with the FDA for Murex Rub-ex.
| Device ID | K954920 |
| 510k Number | K954920 |
| Device Name: | MUREX RUB-EX |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | MUREX DIAGNOSTICS, INC. 3075 NORTHWOODS CIR. Norcross, GA 30071 -1542 |
| Contact | Robert K Shockley |
| Correspondent | Robert K Shockley MUREX DIAGNOSTICS, INC. 3075 NORTHWOODS CIR. Norcross, GA 30071 -1542 |
| Product Code | LQN |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-26 |
| Decision Date | 1996-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647001240 | K954920 | 000 |
| 00613647001233 | K954920 | 000 |
| 08426950590583 | K954920 | 000 |
| 08426950590576 | K954920 | 000 |
| 00006136471240 | K954920 | 000 |
| 00006136471233 | K954920 | 000 |