The following data is part of a premarket notification filed by Laboratory & Specialty Gases, Inc. with the FDA for Clinical Blood Gas Mixture.
| Device ID | K944812 |
| 510k Number | K944812 |
| Device Name: | CLINICAL BLOOD GAS MIXTURE |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | LABORATORY & SPECIALTY GASES, INC. 1180 NORTH MARSHALL AVE. El Lajon, CA 92020 |
| Contact | Frank J Dilaturo |
| Correspondent | Frank J Dilaturo LABORATORY & SPECIALTY GASES, INC. 1180 NORTH MARSHALL AVE. El Lajon, CA 92020 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-02-01 |