The following data is part of a premarket notification filed by Biomedical Research & Development Laboratories Inc with the FDA for Universal(tm) Ion Select Electrode Standards.
| Device ID | K884693 |
| 510k Number | K884693 |
| Device Name: | UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-09 |
| Decision Date | 1988-12-15 |