The following data is part of a premarket notification filed by Cryogenic Rare Gas Laboratories, Inc. with the FDA for Blood Gas Calibration Standard.
| Device ID | K900819 |
| 510k Number | K900819 |
| Device Name: | BLOOD GAS CALIBRATION STANDARD |
| Classification | Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical |
| Applicant | CRYOGENIC RARE GAS LABORATORIES, INC. 913 COMMERCE CIRCLE Hanahan, SC 29410 |
| Contact | Kenneth Dinicola |
| Correspondent | Kenneth Dinicola CRYOGENIC RARE GAS LABORATORIES, INC. 913 COMMERCE CIRCLE Hanahan, SC 29410 |
| Product Code | LCH |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-04-25 |