The following data is part of a premarket notification filed by Liquid Technology Corp. with the FDA for Blood Gas Mixture.
Device ID | K954546 |
510k Number | K954546 |
Device Name: | BLOOD GAS MIXTURE |
Classification | Calibrator, Primary |
Applicant | LIQUID TECHNOLOGY CORP. 6325 NORTH ORANGE BLOSSOM TRAIL, #118 Orlando, FL 32810 |
Contact | Dave Kagrise |
Correspondent | Dave Kagrise LIQUID TECHNOLOGY CORP. 6325 NORTH ORANGE BLOSSOM TRAIL, #118 Orlando, FL 32810 |
Product Code | JIS |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-29 |
Decision Date | 1995-12-28 |