The following data is part of a premarket notification filed by Biomedical Research & Development Laboratories Inc with the FDA for Spectrum(tm) Blood Gas And Electrolyte Control.
| Device ID | K881655 |
| 510k Number | K881655 |
| Device Name: | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | BIOMEDICAL RESEARCH & DEVELOPMENT LABORATORIES INC 4301 WILL ROGERS PKWY. SUITE 1000 Oklahoma City, OK 73108 |
| Contact | Seshachalam Dutta |
| Correspondent | Seshachalam Dutta BIOMEDICAL RESEARCH & DEVELOPMENT LABORATORIES INC 4301 WILL ROGERS PKWY. SUITE 1000 Oklahoma City, OK 73108 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-05-27 |