AUTOPAK-12 Uptake Test Delivery System
by Micromedic Systems 510(k)
Active
510(k) K792662
Overview
The Autopak-12 Uptake Test Delivery System is a radioassay device for triiodothyronine uptake, classified under the Clinical Chemistry specialty. It is a Class II medical device with product code KHQ and regulation number 862.1715.
The device received FDA 510(k) clearance K792662 on January 17, 1980, following a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792662 | Date17 Jan 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KHQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1715
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Micromedic Systems
Questions
What is the Autopak-12 Uptake Test Delivery System used for?
The Autopak-12 Uptake Test Delivery System is a radioassay device designed for measuring triiodothyronine uptake in clinical chemistry laboratories, as specified in its FDA 510(k) clearance documentation.
How was the Autopak-12 Uptake Test Delivery System regulated for market release?
The device received FDA 510(k) clearance through a traditional review process on January 17, 1980, under clearance number K792662, based on a determination of substantial equivalence to a legally marketed predicate device.
What regulatory classification and product code apply to the Autopak-12 Uptake Test Delivery System?
The Autopak-12 Uptake Test Delivery System is classified as a Class II medical device with product code KHQ and is regulated under 21 CFR 862.1715 for radioassay systems in the Clinical Chemistry specialty.