Cleared Traditional

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

K192730 · Biosystems S.A. · Chemistry
Sep 2020
Decision
348d
Days
Class 2
Risk

About This 510(k) Submission

K192730 is an FDA 510(k) clearance for the CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV, a Titrimetric With Edta And Indicator, Calcium (Class II — Special Controls, product code CHW), submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on September 9, 2020, 348 days after receiving the submission on September 27, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K192730 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2019
Decision Date September 09, 2020
Days to Decision 348 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHW — Titrimetric With Edta And Indicator, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145