The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/ml).
Device ID | K062290 |
510k Number | K062290 |
Device Name: | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) |
Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
Contact | Shannon Popson |
Correspondent | Shannon Popson 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 | 2006-08-07 |
Decision Date | 2006-09-01 |
Summary: | summary |