CARESIDE BUN— 510(k) K980057

Substantially Equivalent

Exigent Diagnostics, Inc.

FDA 510(k) clearance K980057 for CARESIDE BUN, Substantially Equivalent on 1998-02-05. Applicant: Exigent Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Exigent Diagnostics, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1998-01-06
Decision date: 1998-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDQ

K203771 — Urea Nitrogen22022-05-31
K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER2014-09-02
K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS2011-04-21
K073295 — UREA/BUN, SCAL, NORTROL, ABTROL2008-05-29
K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP2007-10-12

More clearances from Exigent Diagnostics, Inc.

K982118 — CARESIDE ANALYZER1998-07-24
K981899 — CARESIDE HDL-CHOLESTEROL1998-07-14
K981183 — CARESIDE GLUCOSE1998-05-07
K980043 — CARESIDE CREATININE1998-03-30
K980056 — CARESIDE ANALYZER1998-03-06

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