The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Maclean-fogg, Dispos-inocula-loops.
| Device ID | K842057 |
| 510k Number | K842057 |
| Device Name: | MACLEAN-FOGG, DISPOS-INOCULA-LOOPS |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | POLYMER TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-22 |
| Decision Date | 1984-06-07 |