GDS Enzymatic B-Hydroxybutyrate Reagent Modified

FDA 510(k) K910108 · Gds Diagnostics

Substantially Equivalent

510(k) numberK910108

Submission

Device name
GDS Enzymatic B-Hydroxybutyrate Reagent Modified
Applicant
Gds Diagnostics
Elkhart, IN, US
Received
January 10, 1991
Decision date
March 4, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1435
Specialty
Clinical Chemistry

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Questions and answers

When was GDS Enzymatic B-Hydroxybutyrate Reagent Modified cleared by the FDA?

GDS Enzymatic B-Hydroxybutyrate Reagent Modified (K910108) received a 510(k) decision of Substantially Equivalent on March 4, 1991, 53 days after the submission was received.

What is the product code of K910108?

The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.