I-125 Anti-Microsomal Antibody Irma Test Kit

Q: What is the product code of K871194?

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) K871194 · Cronus

Substantially Equivalent

510(k) numberK871194

Submission

Device name: I-125 Anti-Microsomal Antibody Irma Test Kit
Applicant: Cronus
Carlsbad, CA, US
Received: March 24, 1987
Decision date: April 20, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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

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K971658	Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional	Jay H. Geller	05/23/1997SE
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

More from Light Diagnostics

510(k)	Device	Decision
K871193	I-125 Anti-Thyroglobulin Antibody Irma Test KitJZO · Traditional	05/15/1987SE
K863006	125-I TSH Receptor Antibody KitJZO · Traditional	09/08/1986SE

Questions and answers

When was I-125 Anti-Microsomal Antibody Irma Test Kit cleared by the FDA?

I-125 Anti-Microsomal Antibody Irma Test Kit (K871194) received a 510(k) decision of Substantially Equivalent on April 20, 1987, 27 days after the submission was received.

What is the product code of K871194?

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