HELENA BIOSTRIP K— 510(k) K830976
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K830976 for HELENA BIOSTRIP K, Substantially Equivalent on 1983-05-04. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- 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
- Mchenry, IL, 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 Helena Laboratories
view all- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Data sourced from openFDA. This site is unofficial and independent of the FDA.