KDW — Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Class I
FDA product code KDW covers "Container, Specimen Mailer And Storage, Temperature Controlled, Sterile", a Class I medical device regulated under 21 CFR 864.3250. Submissions are reviewed by the Pathology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDW
- Device Class
- Class I
- Regulation Number
- 864.3250
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970580 | substance abuse specialties | SASI-DC1TS | April 17, 1997 |
| K951122 | harry a. schlakman | CAPITOL URINE DRUG SCREEN COLLECTION KIT | May 5, 1995 |
| K931474 | gbf medical group | DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS | May 10, 1994 |
| K913967 | doxtech | DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM | October 18, 1991 |