The following data is part of a premarket notification filed by Integrated Laboratory Automation Solutions, Inc. with the FDA for Integrated Laboratory Automation Solution.
| Device ID | K091975 |
| 510k Number | K091975 |
| Device Name: | INTEGRATED LABORATORY AUTOMATION SOLUTION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-03-10 |
| Summary: | summary |