The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Modification Of Abl Mic-10 Precept Sys.
| Device ID | K843612 |
| 510k Number | K843612 |
| Device Name: | MODIFICATION OF ABL MIC-10 PRECEPT SYS |
| Classification | Paraquat Assay |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620 MANOR ROAD Austin , TX 78723 - |
| Contact | Rex L Bradley |
| Correspondent | Rex L Bradley AUSTIN BIOLOGICAL LABORATORIES 6620 MANOR ROAD Austin , TX 78723 - |
| Product Code | LTD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-13 |
| Decision Date | 1985-02-19 |