TEST, AMMONIA, BMC REAGENTSET— 510(k) K770273

Name: FDA 510(k) clearance K770273
Creator: U.S. Food and Drug Administration
Published: 1977-03-01

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K770273 for TEST, AMMONIA, BMC REAGENTSET, Substantially Equivalent on 1977-03-01. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1977-02-14
Decision date: 1977-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIF

view all

K183517 — Ammonia II2019-02-08
K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)2013-03-07
K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE2013-02-15
K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE2006-09-06
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25

More clearances from Boehringer Mannheim Corp.

view all

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

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