The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Lifespan Co2.
| Device ID | K812643 |
| 510k Number | K812643 |
| Device Name: | LIFESPAN CO2 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BIOCHEM INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-16 |
| Decision Date | 1981-11-16 |