Urine Collection Containers, #3600 & 3610
by The Healthcare Group Laboratories, Inc.
510(k) K801786
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801786 | Date30 Sep 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Urine Collection Containers, #3600 & 3610, are medical devices designed for the collection of urine samples. These containers are intended to facilitate the storage and transport of urine specimens for clinical analysis.
These containers are available in models #3600 and #3610. The device is regulated under FDA 510(k) clearance K801786.
Other devices from The Healthcare Group Laboratories, Inc.
See all devices from The Healthcare Group Laboratories, Inc. →
Questions
AI-generated answers, 6 Oct 2026
What are the Urine Collection Containers #3600 and #3610 used for?
The Urine Collection Containers, models #3600 and #3610, are medical devices specifically designed to facilitate the collection, storage, and transport of urine specimens for clinical analysis.
What models are available for these collection containers?
These containers are available in two distinct models, #3600 and #3610, to accommodate different clinical collection requirements.
What is the regulatory status of these urine collection containers?
The Urine Collection Containers are regulated under FDA 510(k) clearance K801786, which was granted on September 30, 1980.