Amresco Flow Pac Creatine Phosphokinase Reagent
510(k) K860663
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860663 | Date11 Apr 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JHY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
This device is a colorimetric method reagent for creatine phosphokinase (CPK) or its isoenzymes, as defined by its device type and classification. It is intended for use in clinical chemistry laboratories to measure CPK activity in biological specimens.
The reagent is supplied as a diagnostic reagent for in vitro use and is regulated under FDA 510(k) clearance K860663. It is classified as a Class II medical device with product code JHY and regulation number 862.1215, and was cleared on April 11, 1986, following a traditional 510(k) review.
Other devices from Amresco, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Amresco Flow Pac Creatine Phosphokinase reagent used for?
It is a colorimetric reagent designed for clinical chemistry laboratories to quantify creatine phosphokinase (CPK) activity or its isoenzymes in biological specimens, helping clinicians assess muscle damage or related conditions.
How is the reagent supplied and is it sterile?
The product is supplied as an in‑vitro diagnostic reagent intended for laboratory use. It is provided sterile for direct addition to test samples, ensuring reliable colorimetric reactions without contamination.
Is the reagent single‑use or can it be reused?
The reagent is intended for single‑use applications per test batch. Once opened, aliquots should be used according to the manufacturer’s instructions and any remaining material discarded to maintain assay integrity.
What regulatory pathway was used for this device?
The reagent was cleared through the FDA 510(k) process (traditional review) under clearance number K860663, indicating it is substantially equivalent to a previously marketed device.