The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Spottest Iodine Solution Dobell & O'connor.
| Device ID | K851481 |
| 510k Number | K851481 |
| Device Name: | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR |
| Classification | Stains, Chemical Solution |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | LED |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-04-29 |