Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
A sterile temperature-controlled specimen mailer and storage container is a device designed to collect, store, and transport biological specimens under temperature-regulated conditions, ensuring specimen integrity and viability for laboratory analysis, particularly for temperature-sensitive samples. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KDW 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
- KDW
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970580 | SASI-DC1TS | Apr 17, 1997 | Substantially Equivalent | Substance Abuse Specialties, Inc. |
| K951122 | CAPITOL URINE DRUG SCREEN COLLECTION KIT | May 05, 1995 | Substantially Equivalent | Harry A. Schlakman |
| K931474 | DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS | May 10, 1994 | Unknown | Gbf Medical Group |
| K913967 | DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM | Oct 18, 1991 | Substantially Equivalent | Doxtech, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.