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 |