The following data is part of a premarket notification filed by Advanced Biomedical Methods, Inc. with the FDA for Single Reagent Calcium For Demand Analyzer.
| Device ID | K880949 |
| 510k Number | K880949 |
| Device Name: | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER |
| Classification | Azo Dye, Calcium |
| Applicant | ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Contact | Goldberg, Phd |
| Correspondent | Goldberg, Phd ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-04-05 |