The following data is part of a premarket notification filed by Microchem Laboratories, Inc. with the FDA for Aldahol V High Level Disinfectant.
| Device ID | K113015 |
| 510k Number | K113015 |
| Device Name: | ALDAHOL V HIGH LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | MICROCHEM LABORATORIES, INC. 1107-C SOUTH AIRPORT CIRCLE Euless, TX 76040 |
| Contact | Norman Miner |
| Correspondent | Norman Miner MICROCHEM LABORATORIES, INC. 1107-C SOUTH AIRPORT CIRCLE Euless, TX 76040 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868956000235 | K113015 | 000 |