Container, Specimen Mailer And Storage, Sterile
A sterile specimen mailer and storage container is a sealed, sterile device used to collect, store, and transport biological specimens such as tissue, fluids, or microbiological samples for laboratory analysis, maintaining specimen integrity during transit. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KDT is regulated under 21 CFR 864.3250 in the Pathology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KDT
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873593 | BIOSURE SPECIMEN COLLECTION CONTAINER | Nov 25, 1987 | Substantially Equivalent | Biosure, Inc. |
| K862665 | NOVACYTE-U | Sep 04, 1986 | Substantially Equivalent | Xsirius Medical, Inc. |
| K834579 | BIOSPAL 2400S | Feb 04, 1984 | Substantially Equivalent | Hospal Medical Corp. |
| K834412 | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | Jan 13, 1984 | Substantially Equivalent | Preventive Diagnostics Corp. |
| K833660 | PRESERV PVA FIXATIVE -MALIN PACK | Nov 28, 1983 | Substantially Equivalent | Preventive Diagnostics Corp. |
| K823773 | PROVIAL II #006-010-0201 | Jan 21, 1983 | Substantially Equivalent | Dynatech Corp. |
| K822870 | STOOL-COLLECTION/PRESERVATION KIT | Nov 01, 1982 | Substantially Equivalent | American Scientific Products |
| K821621 | PREGNOPOST | Jul 21, 1982 | Substantially Equivalent | M.M. Wolfred, Ph.D. |
| K820246 | PREFILLED SPECIMEN CONTAINER | Feb 18, 1982 | Substantially Equivalent | Sage Products, Inc. |
| K811793 | FIX-RIGHT 90ML & 180 ML PREFILLED CONT | Jul 31, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K800946 | URINARY CATHETER SAMPLING KIT | Jun 20, 1980 | Substantially Equivalent | Sage Products, Inc. |
| K770071 | PINLOCK CONTAINER | Feb 24, 1977 | Substantially Equivalent | Perkins Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 114 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 114 registration numbers. Click on an entry to view related FDA registrations.