The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Abl555 Blood Gas, Electrolyte & Metabolite System.
| Device ID | K974818 |
| 510k Number | K974818 |
| Device Name: | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-01-16 |
| Summary: | summary |