Twin Bun/Glucose

FDA 510(k) K861775 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK861775

Submission

Device name
Twin Bun/Glucose
Applicant
Boehringer Mannheim Corp.
Indianapolis, IN, US
Received
May 8, 1986
Decision date
June 27, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CDW – Diacetyl-Monoxime, Urea Nitrogen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1770
Specialty
Clinical Chemistry

Other 510(k)s with product code CDW

510(k)DeviceApplicantDecision
K874532Blood Urea NitrogenCDW · Traditional Catachem, Inc.01/05/1988SE
K871320Flow-Pac Urea Nitrogen Reagent Set 2214, 2814CDW · Traditional American Research Products Co.04/22/1987SE
K863425Amresco Flow Pac Urea Nitrogen Reagents #1346CDW · Traditional American Research Products Co.10/01/1986SE
K860419Urea Nitrogen Reagent SetCDW · Traditional Sterling Diagnostics, Inc.02/11/1986SE
K850937UreaCDW · Traditional Dilab, Inc.06/10/1985SE
K844156Urea Nitrogen Reagent SetCDW · Traditional Livonia Diagnostics, Inc.11/13/1984SE
K841068Urea Nitrogen Reagent SetCDW · Traditional Medical Specialties, Inc.05/01/1984SE
K822323Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional Harleco Diagnostics09/02/1982SE
K821212Urea Nitrogen Reagent SetCDW · Traditional Omega Medical Electronics07/22/1982SE
K813415Urea Nitrogen Reagent SetCDW · Traditional Anco Medical Reagents & Assoc.12/31/1981SE

More from Anco Medical Reagents & Assoc.

510(k)DeviceDecision
K984326Elecys Ige AssayJHR · Traditional 02/08/1999SE
K983047Accu-Chek HQ SystemLFR · Traditional 02/05/1999SE
K984419Elecsys Ige CalcheckJJY · Traditional 02/02/1999SE
K984425Modification of Preciset Serum Proteins CalibratorJIX · Traditional 01/20/1999SE
K984372Elecsys Calcheck Troponin TJJY · Traditional 12/14/1998SE
K984105Elecsys Troponin T Stat TestMMI · Traditional 12/08/1998SE
K983503Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional 12/01/1998SE
K983469Preciset Serum Proteins CalibratorJIX · Traditional 11/25/1998SE
K983185Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional 11/12/1998SE
K983510Chemstrip 101 Urine AnalyzerKQO · Special 10/27/1998SE

Questions and answers

When was Twin Bun/Glucose cleared by the FDA?

Twin Bun/Glucose (K861775) received a 510(k) decision of Substantially Equivalent on June 27, 1986, 50 days after the submission was received.

What is the product code of K861775?

The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.