The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Gemcal Eni Reference Serum.
| Device ID | K844344 |
| 510k Number | K844344 |
| Device Name: | GEMCAL ENI REFERENCE SERUM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BIOCELL LABORATORIES, INC. 1117 E. JANIS ST. Carson, CA 90746 |
| Contact | Falkowski |
| Correspondent | Falkowski BIOCELL LABORATORIES, INC. 1117 E. JANIS ST. Carson, CA 90746 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1985-01-03 |