TMB Chromogen/Substrate Reagent Set
510(k) K920918
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920918 | Date7 Apr 1992 | 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- Withdrawn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
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The TMB Chromogen/Substrate Reagent Set is a device used in clinical chemistry for visual detection of pregnancy hCG. It is classified as a Class II medical device under regulation 862.1155.
This reagent set received FDA 510(k) clearance (K920918) on April 7, 1992, and is substantially equivalent to a predicate device. It is intended for prescription use and is manufactured by Bio Clinic Co. in St. Louis, Missouri.
Other devices from Bio Clinic Co.
Questions
AI-generated answers, 26 Sep 2026
What is the TMB Chromogen/Substrate Reagent Set used for?
The TMB Chromogen/Substrate Reagent Set is used in clinical chemistry for the visual detection of pregnancy hCG, as specified in its FDA 510(k) clearance documentation.
How is the TMB Chromogen/Substrate Reagent Set supplied and is it sterile or single-use?
The device data does not specify the supply format, sterility, or single-use/reuse status of the TMB Chromogen/Substrate Reagent Set; these details are not included in the provided information.
What regulatory pathway was used for the TMB Chromogen/Substrate Reagent Set and what is its classification?
The TMB Chromogen/Substrate Reagent Set received FDA 510(k) clearance (K920918) and is classified as a Class II medical device under regulation 862.1155 for prescription use.