The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Spottest Loeffler Methylene Blue Stain.
| Device ID | K843919 |
| 510k Number | K843919 |
| Device Name: | SPOTTEST LOEFFLER METHYLENE BLUE STAIN |
| Classification | Methylene Blue, Tissue Stain |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 1058-A Detroit, MI 48232 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 1058-A Detroit, MI 48232 |
| Product Code | KFC |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-05 |
| Decision Date | 1984-10-30 |