The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Par Tdm.
| Device ID | K032826 |
| 510k Number | K032826 |
| Device Name: | MAS PAR TDM |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Penny M Layman |
| Correspondent | Penny M Layman MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-10 |
| Decision Date | 2003-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011694 | K032826 | 000 |
| 00884883002432 | K032826 | 000 |
| 00884883002425 | K032826 | 000 |
| 00884883002418 | K032826 | 000 |