Ria-Gnost Insulin

FDA 510(k) K890837 · Cambridge Medical Technology

Substantially Equivalent

510(k) numberK890837

Submission

Device name
Ria-Gnost Insulin
Applicant
Cambridge Medical Technology
Billerica, MA, US
Received
February 21, 1989
Decision date
April 26, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFP – Radioimmunoassay, Immunoreactive Insulin
Device class
Class I (low risk)
Regulation
21 CFR 862.1405
Specialty
Clinical Chemistry

Other 510(k)s with product code CFP

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K963911Alpco/Mercodia Insulin ElisaCFP · Traditional American Laboratory Products Co., Ltd.11/01/1996SE
K953084Access Ultrasensitive Insulin AssayCFP · Traditional Bio-Rad Laboratories, Inc.09/25/1995SE
K920109Imx InsulinCFP · Traditional Abbott Laboratories05/07/1992SE
K914820DSL Insulin Ria (DSL 1600)CFP · Traditional Diagnostic Systems Laboratories, Inc.01/09/1992SE
K903628Aia-Pack IriCFP · Traditional Tosoh Corp.09/07/1990SE
K901135Enzymun Test(R) InsulinCFP · Traditional Boehringer Mannheim Corp.04/03/1990SE
K896572Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional Helena Laboratories01/11/1990SE
K851071Pharmacia Insulin RiaCFP · Traditional Pharmacia, Inc.04/12/1985SE
K841573Insulin Radioimmunoassay KitCFP · Traditional Sorin Biomedica, Fiat, USA, Inc.05/16/1984SE
K823939Wako Insulin TestCFP · Traditional Wako Chemicals USA, Inc.01/28/1983SE

More from Wako Chemicals USA, Inc.

510(k)DeviceDecision
K890836Ria-Gnost ProgesteroneJLS · Traditional 03/16/1989SE
K890697Ria-Gnost FerritinJMG · Traditional 03/16/1989SE
K873737No Spin(Tm) T3 Coated Tube RadioimmunoassayCDP · Traditional 11/24/1987SE
K870573T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional 04/22/1987SE
K862871Radioimmunoassay of No Spin(Tm) CortisolCGR · Traditional 08/19/1986SE
K860130Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional 02/19/1986SE
K855169T3 Uptake Radioimmunoassay KitKHQ · Traditional 02/06/1986SE
K850254Parathyroid Hormone Radioimmunoassay KitCEW · Traditional 04/03/1985SE
K843635Matched Component Set for Radioimmuno-JKC · Traditional 09/28/1984SE
K841042Matched Component Set RadioimmunoassayCDZ · Traditional 04/19/1984SE

Questions and answers

When was Ria-Gnost Insulin cleared by the FDA?

Ria-Gnost Insulin (K890837) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 64 days after the submission was received.

What is the product code of K890837?

The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.