The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Mic And Mic/id Panels, Chloramphenicol.
Device ID | K992593 |
510k Number | K992593 |
Device Name: | PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL |
Classification | Susceptibility Test Discs, 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 | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-03 |
Decision Date | 1999-10-14 |
Summary: | summary |