Hema-Trol Q-Check

FDA 510(k) K952385 · Medical Specialties Intl., Inc.

Substantially Equivalent

510(k) numberK952385

Submission

Device name
Hema-Trol Q-Check
Applicant
Medical Specialties Intl., Inc.
South Plainfield, NJ, US
Received
May 22, 1995
Decision date
September 25, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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Questions and answers

When was Hema-Trol Q-Check cleared by the FDA?

Hema-Trol Q-Check (K952385) received a 510(k) decision of Substantially Equivalent on September 25, 1995, 126 days after the submission was received.

What is the product code of K952385?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.