KDT — Container, Specimen Mailer And Storage, Sterile Class I
FDA product code KDT covers "Container, Specimen Mailer And Storage, Sterile", a Class I medical device regulated under 21 CFR 864.3250. Submissions are reviewed by the Pathology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDT
- 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 |
|---|---|---|---|
| K873593 | biosure | BIOSURE SPECIMEN COLLECTION CONTAINER | November 25, 1987 |
| K862665 | xsirius medical | NOVACYTE-U | September 4, 1986 |
| K834579 | hospal medical | BIOSPAL 2400S | February 4, 1984 |
| K834412 | preventive diagnostics | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | January 13, 1984 |
| K833660 | preventive diagnostics | PRESERV PVA FIXATIVE -MALIN PACK | November 28, 1983 |
| K823773 | dynatech | PROVIAL II #006-010-0201 | January 21, 1983 |
| K822870 | american scientific products | STOOL-COLLECTION/PRESERVATION KIT | November 1, 1982 |
| K821621 | m.m. wolfred, ph.d | PREGNOPOST | July 21, 1982 |
| K820246 | sage products | PREFILLED SPECIMEN CONTAINER | February 18, 1982 |
| K811793 | richard-allan medical ind | FIX-RIGHT 90ML & 180 ML PREFILLED CONT | July 31, 1981 |
| K800946 | sage products | URINARY CATHETER SAMPLING KIT | June 20, 1980 |
| K770071 | perkins mfg | PINLOCK CONTAINER | February 24, 1977 |