The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Document Salicylate Cal Ver.
| Device ID | K041073 |
| 510k Number | K041073 |
| Device Name: | DOCUMENT SALICYLATE CAL VER |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | David Casal |
| Correspondent | David Casal MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-05-21 |
| Summary: | summary |