The following data is part of a premarket notification filed by Advanced Biomedical Methods, Inc. with the FDA for Total Bilirubin For Demand Analyzer.
| Device ID | K844243 |
| 510k Number | K844243 |
| Device Name: | TOTAL BILIRUBIN FOR DEMAND ANALYZER |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | ADVANCED BIOMEDICAL METHODS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Jack M Goldberg |
| Correspondent | Jack M Goldberg ADVANCED BIOMEDICAL METHODS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1985-01-03 |