The following data is part of a premarket notification filed by Alere, San Diego, Dba Biosite Incorporated, Dba In with the FDA for Lipid Controls; Multi- Analyte Control; Multi-analyte Calibration Verification Materials.
| Device ID | K102700 |
| 510k Number | K102700 |
| Device Name: | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road San Diego, CA 92121 |
| Contact | Edward Brehm |
| Correspondent | Edward Brehm ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2010-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893038002845 | K102700 | 000 |
| 00893038002210 | K102700 | 000 |
| 00893038002036 | K102700 | 000 |
| 00893038002029 | K102700 | 000 |
| 00893038002012 | K102700 | 000 |