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 |