Mouse Liver Kidney Stomach Diagnostic Test Kit

Q: What is the product code of K971658?

The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.

FDA 510(k) K971658 · Jay H. Geller

Substantially Equivalent

510(k) numberK971658

Submission

Device name: Mouse Liver Kidney Stomach Diagnostic Test Kit
Applicant: Jay H. Geller
Santa Monica, CA, US
Received: April 14, 1997
Decision date: May 23, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5660
Specialty: Immunology

Other 510(k)s with product code DBL

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K974169	Wielisa Anti-Gbm Test SystemDBL · Traditional	Wieslab AB	02/17/1998SE
K971464	Immunoscan Anti-Gbm Quantitative KitDBL · Traditional	Euro-Diagnostica AB	10/29/1997SE
K963525	Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional	Shield Diagnostics, Ltd.	11/07/1996SE
K955431	Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional	The Binding Site, Ltd.	04/23/1996SE
K953495	Eia Kit for the Detection of GBM AntibodiesDBL · Traditional	Scimedx Corp.	04/10/1996SE
K944192	Anti-Nuclear Antibody (Ana) Test Kit W/Rat LiverDBL · Traditional	Light Diagnostics	03/06/1995SE
K944191	Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional	Light Diagnostics	03/06/1995SE
K913360	Anti-Reticulin Antibody (Ara) TestDBL · Traditional	Immco Diagnostics, Inc.	09/26/1994SE

More from Immco Diagnostics, Inc.

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K942326	Human C5 Rid KitsDAY · Traditional	08/24/1995SE
K950015	Human Protein C Rid Test KitGGP · Traditional	03/06/1995SE
K943334	Hawley Retainer Orthodontic Applicance KitDZC · Traditional	10/05/1994SE

Questions and answers

When was Mouse Liver Kidney Stomach Diagnostic Test Kit cleared by the FDA?

Mouse Liver Kidney Stomach Diagnostic Test Kit (K971658) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 39 days after the submission was received.

What is the product code of K971658?

The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.