The following data is part of a premarket notification filed by Alere San Diego Inc. Dba Biosite,innovacon,hemosen with the FDA for Alere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu Cassette.
| Device ID | K120615 |
| 510k Number | K120615 |
| Device Name: | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Edward Brehm, Ph.d. |
| Correspondent | Edward Brehm, Ph.d. ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Product Code | CGA |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JJE |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-29 |
| Decision Date | 2013-05-15 |
| Summary: | summary |