The following data is part of a premarket notification filed by Advanced Biomedical Methods, Inc. with the FDA for Ggtp Reagent/serum Iron/salicylate Demand Analyzer.
| Device ID | K852027 |
| 510k Number | K852027 |
| Device Name: | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER |
| Classification | Colorimetry, Salicylate |
| Applicant | ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Contact | Jack M Goldberg |
| Correspondent | Jack M Goldberg ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-08 |
| Decision Date | 1985-05-29 |