SPECIFIC GRAVITY INSTRUMENT— 510(k) K831213

Substantially Equivalent

Iris

FDA 510(k) clearance K831213 for SPECIFIC GRAVITY INSTRUMENT, Substantially Equivalent on 1983-06-30. Applicant: Iris. Device class: 1.

Clearance details

Applicant: Iris
Product code: Code JRE
Device class: Class 1
Regulation: 21 CFR 862.2800
Advisory panel: Clinical Chemistry
Date received: 1983-04-14
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRE

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K941901 — MODEL 2721 CLINICAL REFRACTOMETER1995-01-17
K941903 — MODEL 2740 CLINICAL REFRACTOMETER1995-01-17
K941906 — MODEL 2730 CLINICAL REFRACTOMETER1995-01-17
K941902 — MODEL 3471 CLINICAL REFRACTOMETER1994-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.