URIC ACID PAP— 510(k) K873363

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K873363 for URIC ACID PAP, Substantially Equivalent on 1987-10-19. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1987-08-21
Decision date: 1987-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNK

K102568 — URIC ACID MODEL 3P392011-05-06
K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X982007-04-06
K040467 — VITALAB URIC ACID REAGENT2004-03-08
K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR2003-07-15
K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM2003-03-18

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 K873363

K-number listed on FDA's recall record

Z-1931-2015 — Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.Class II·Terminated·Roche Diagnostics Operations, Inc.·20150507

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K873363.

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