The following data is part of a premarket notification filed by Adeza Biomedical with the FDA for Romcheck Specimen Collection Kit.
| Device ID | K900225 |
| 510k Number | K900225 |
| Device Name: | ROMCHECK SPECIMEN COLLECTION KIT |
| Classification | Device, Specimen Collection |
| Applicant | ADEZA BIOMEDICAL 1240 ELKO DR. Sunnyvale, CA 94089 |
| Contact | E Charlton,phd |
| Correspondent | E Charlton,phd ADEZA BIOMEDICAL 1240 ELKO DR. Sunnyvale, CA 94089 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045514768 | K900225 | 000 |