The following data is part of a premarket notification filed by American Dade with the FDA for Dade Alcohol & Ammonia Controls Level I-low & Ii H.
Device ID | K850575 |
510k Number | K850575 |
Device Name: | DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | James E Keller |
Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-13 |
Decision Date | 1985-04-10 |