GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED— 510(k) K910108
Substantially EquivalentGds Diagnostics
FDA 510(k) clearance K910108 for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED, Substantially Equivalent on 1991-03-04. Applicant: Gds Diagnostics. Device class: 1.
Clearance details
- Applicant
- Gds Diagnostics
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code JIN
view all- K201551 — KetoSens BT Blood B-Ketone Monitoring System
- K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System
- K182593 — KET-1 Blood Ketone Monitoring System
- K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
- K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
More clearances from Gds Diagnostics
view allRecalls naming K910108
K-number listed on FDA's recall record- Z-2199-2021 — Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
- Z-2200-2021 — Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
- Z-2201-2021 — Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Z-2202-2021 — Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Z-2203-2021 — Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910108.
Data sourced from openFDA. This site is unofficial and independent of the FDA.