The following data is part of a premarket notification filed by American Dade with the FDA for Aqueous Blood Gas/electrolyte Contr Lev I,ii & Iii.
Device ID | K872196 |
510k Number | K872196 |
Device Name: | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III |
Classification | Controls For Blood-gases, (assayed And Unassayed) |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | JJS |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-07-31 |