The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Mic And Mic/id Panels.
Device ID | K001721 |
510k Number | K001721 |
Device Name: | PASCO MIC AND MIC/ID PANELS |
Classification | Panels, Test, Susceptibility, Antimicrobial |
Applicant | PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
Contact | Linda K Dillon |
Correspondent | Linda K Dillon PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
Product Code | LTT |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-06 |
Decision Date | 2000-08-04 |