The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas, Dade And Liquid Assayed Diabetes Control.
Device ID | K042717 |
510k Number | K042717 |
Device Name: | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
Contact | Mary Thorsness |
Correspondent | Mary Thorsness MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-30 |
Decision Date | 2004-11-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883004429 | K042717 | 000 |
00884883003521 | K042717 | 000 |
00884883003514 | K042717 | 000 |