The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Igentamicin Reagents; Architect Igentamicin Calibrators.
| Device ID | K102699 |
| 510k Number | K102699 |
| Device Name: | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6 AP6C-2 Abbott Park, IL 60064 -6092 |
| Contact | Judith Wallach |
| Correspondent | Judith Wallach ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6 AP6C-2 Abbott Park, IL 60064 -6092 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2011-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740001742 | K102699 | 000 |
| 00380740001735 | K102699 | 000 |