510(k) Report

Devices descending from K954723

17 later devices reach Enzyme Immunoassay Ana Screening Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc.200411
+1K021257Ana Line Blot, Catalog Number: Kalabi (20 Tests)Diagnostic Products Corp.20020—
+1K992041Relisa Ana Screening Test System, Model 7096-11Immuno Concepts, Inc.19990—
+1K984462Liquichek Ena Control, Eia Screen, Model NO. 206Bio-Rad19980—
+1K984476Liquichek Anti-RNP Control, Eia, Model 207Bio-Rad19981—
+1K984479Liquichek Anti-SM Control, Eia, Model 208Bio-Rad19981—
+1K984473Liquichek Ana Control, Eia Screen, Model 205Bio-Rad19980—
+1K984470Liquichek Anti-SS-a Control, Eia, Model 209Bio-Rad19981—
+1K984475Liquichek Anti-SCL-70 Control, Eia, Model 212Bio-Rad19981—
+1K984464Liquichek Anti-JO 1 Control, Eia, Model NO. 211Bio-Rad19980—
+1K984478Liquichek Anti-SS-B Control, Eia, Model 210Bio-Rad19981—
+2K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems20090—
+2K024218Liquichek Anti-SS-a Control, Positive, Catalog #114Bio-Rad20030—
+2K024232Liquichek Anti-SS-B Control, Positive, Catalog #113Bio-Rad20030—
+2K024219Liquichek Anti-SM Control, Positive, Catalog #115Bio-Rad20030—
+2K024223Liquichek Anti-RNP Control, Positive, Catalog #116Bio-Rad20030—
+2K024226Liquichek Anti-SCL-70 Control, Positive, Catalog #116Bio-Rad20030—