The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Microstrep Plus Panel Erythromycin (0.015 To 2 Mcg/ml).
Device ID | K062375 |
510k Number | K062375 |
Device Name: | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) |
Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
Contact | Maureen Mende |
Correspondent | Maureen Mende DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
Product Code | LRG |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-15 |
Decision Date | 2006-10-26 |
Summary: | summary |