The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Mic-bio-plate.
Device ID | K844903 |
510k Number | K844903 |
Device Name: | MIC-BIO-PLATE |
Classification | Manual Antimicrobial Susceptibility Test Systems |
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 | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-14 |
Decision Date | 1984-12-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIC-BIO-PLATE 73158092 1119459 Dead/Expired |
PASCO LABORATORIES, INC. 1978-02-08 |