The following data is part of a premarket notification filed by Stat Path with the FDA for Stat Fix Microwave Irradiation Medium.
| Device ID | K882362 |
| 510k Number | K882362 |
| Device Name: | STAT FIX MICROWAVE IRRADIATION MEDIUM |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
| Contact | R Bostwick |
| Correspondent | R Bostwick STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-06-22 |