The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Candida Detection System.
| Device ID | K823016 |
| 510k Number | K823016 |
| Device Name: | CANDIDA DETECTION SYSTEM |
| Classification | Antigen, Id, Candida Albicans |
| Applicant | RAMCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHK |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1982-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600000686024 | K823016 | 000 |
| 78600000686023 | K823016 | 000 |
| 28600000686028 | K823016 | 000 |
| 18600000686021 | K823016 | 000 |