The following data is part of a premarket notification filed by Biocare Corp. with the FDA for Biolyte 2000 Na+,k+,cl-/li+electrolyte Analyzer.
| Device ID | K002855 |
| 510k Number | K002855 |
| Device Name: | BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | BIOCARE CORP. 200 PROSPECT ST. Waltham, MA 02454 |
| Contact | Paul W Mcdonald |
| Correspondent | Paul W Mcdonald BIOCARE CORP. 200 PROSPECT ST. Waltham, MA 02454 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-10-12 |