The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop(tm) Lactophenol Aniline Blue.
| Device ID | K913005 |
| 510k Number | K913005 |
| Device Name: | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JIO |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838023835 | K913005 | 000 |