The following data is part of a premarket notification filed by Medical Chemical Corp. with the FDA for Con-kit.
| Device ID | K941129 |
| 510k Number | K941129 |
| Device Name: | CON-KIT |
| Classification | Device, Parasite Concentration |
| Applicant | MEDICAL CHEMICAL CORP. 1909 CENTINELA AVE. Santa Monica, CA 90404 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten MEDICAL CHEMICAL CORP. 1909 CENTINELA AVE. Santa Monica, CA 90404 |
| Product Code | LKS |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-09 |
| Decision Date | 1994-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M445695ASAMPLE1 | K941129 | 000 |
| M445693AESEDEA50PACK1 | K941129 | 000 |
| M445693AFUNNEL1 | K941129 | 000 |
| M445693ASAMPLE1 | K941129 | 000 |
| M445694A1 | K941129 | 000 |
| M445694AEA1 | K941129 | 000 |
| M445694ASAMPLE1 | K941129 | 000 |
| M445694ATUBEFUNNEL1 | K941129 | 000 |
| M445695A1 | K941129 | 000 |
| M445695AEA1 | K941129 | 000 |
| M445693A50PACK1 | K941129 | 000 |