ALBUMIN BCP— 510(k) K844426

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K844426 for ALBUMIN BCP, Substantially Equivalent on 1985-01-07. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1984-11-15
Decision date: 1985-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJW

K203530 — Albumin BCP22022-03-18
K193001 — Albumin BCP2019-12-19
K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR2013-10-16
K021636 — ALBUMIN REAGENT2002-07-17
K000483 — RANDOX ALBUMIN2000-03-31

More clearances from Boehringer Mannheim Corp.

K984326 — ELECYS IGE ASSAY1999-02-08
K983047 — ACCU-CHEK HQ SYSTEM1999-02-05
K984419 — ELECSYS IGE CALCHECK1999-02-02
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

Recalls naming K844426

K-number listed on FDA's recall record

Z-1194-2019 — Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.Class II·Terminated·Roche Diagnostics Corporation·20190318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K844426.

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