Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DEW — Predicate Candidate Screening
76 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
129 days90th percentile
76clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050113 | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2005-02-08 | 21 | 0 |
| K040434 | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2004-03-10 | 20 | 0 |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | 2001-03-15 | 14 | 0 |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN | Wako Chemicals USA, Inc. | 2000-01-18 | 61 | 0 |
| K993281 | K-ASSAY IGG | Kamiya Biomedical Co. | 1999-11-09 | 40 | 0 |
| K983221 | IGG | Abbott Laboratories | 1998-11-04 | 51 | 0 |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | 1997-03-06 | 76 | 2 |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | 1997-03-06 | 155 | 0 |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA | Beckman Instruments, Inc. | 1997-02-10 | 137 | 2 |
| K962202 | QUANTEX IGG | Instrumentation Laboratory CO | 1996-09-26 | 111 | 0 |
| K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 | 105 | 0 |
| K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, U | Beckman Instruments, Inc. | 1995-05-15 | 38 | 0 |
| K943997 | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | 1994-10-03 | 48 | 0 |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | 1994-04-21 | 230 | 0 |
| K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | 1993-09-08 | 63 | 0 |
| K924197 | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | 1992-12-15 | 117 | 0 |
| K921575 | IGG SUCLASS EIA | Virotech Diagnostika | 1992-05-28 | 56 | 0 |
| K911610 | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | Janssen Research Foundation | 1991-06-12 | 79 | 0 |
| K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1990-04-26 | 57 | 0 |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Coulter Immunology | 1989-08-03 | 93 | 0 |
| K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) | Vitek Systems, Inc. | 1989-04-18 | 40 | 0 |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Atlantic Antibodies | 1989-02-22 | 29 | 0 |
| K882369 | ACCRAASSAY RID KITS | Icn Immunobiologicals | 1988-07-12 | 34 | 0 |
| K882083 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-07-08 | 51 | 0 |
| K880784 | WAKO(TM) IGG-HA DIRECT | Wako Chemicals USA, Inc. | 1988-06-06 | 101 | 0 |
| K875254 | GULLSORB IGG INACTIVATION REAGENT | Gull Laboratories, Inc. | 1988-02-17 | 57 | 0 |
| K875356 | IMMUNOGLOBULIN G & G SUBCLASSES | Birmingham | 1988-02-10 | 41 | 0 |
| K873870 | IMMUNOGLOBULINS G | Unipath , Ltd. | 1987-10-13 | 50 | 0 |
| K872800 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT | Abbott Laboratories | 1987-08-12 | 28 | 0 |
| K871340 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-04-22 | 20 | 0 |
| K871352 | PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS | Helena Laboratories | 1987-04-22 | 16 | 0 |
| K862764 | TINA-QUANT(R) IGG | Boehringer Mannheim Corp. | 1986-09-03 | 43 | 0 |
| K861059 | DAKO ITA SYSTEM | Dako Corp. | 1986-08-25 | 159 | 0 |
| K853465 | GILFORD IMMUNOGLOBULIN G REAGENT | Gilford | 1985-09-16 | 28 | 0 |
| K852589 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT | Abbott Laboratories | 1985-07-15 | 27 | 0 |
| K851541 | DART IMMUNOGLOBULINS REAGENT SYSTEM | Coulter Electronics, Inc. | 1985-07-15 | 90 | 0 |
| K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G | Applications Lab | 1985-03-01 | 16 | 0 |
| K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K841816 | OPTIMATE IGG TEST | Miles Laboratories, Inc. | 1984-06-22 | 52 | 0 |
| K833402 | TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN | Technicon Instruments Corp. | 1984-01-24 | 116 | 0 |
| K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC | Gelco Diagnostics, Inc. | 1983-10-31 | 123 | 0 |
| K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN | Gelco Diagnostics, Inc. | 1983-10-28 | 120 | 0 |
| K831101 | TIA-IGG REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | 22 | 0 |
| K830594 | TITAN IMMUNO-FIX | Helena Laboratories | 1983-03-24 | 28 | 0 |
| K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED | Microbiological Research Corp. | 1982-04-29 | 17 | 0 |
| K812484 | DAKO PAP KIT K505 | Dako Corp. | 1982-02-10 | 163 | 0 |
| K812664 | ACA IMMUNOGLOBULIN G ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-02 | 11 | 0 |
| K812630 | ACA IMMUNOGLOBULIN G CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | 14 | 0 |
| K812453 | SCRIPPSYSTEM IMMUNOGLOBIN RID KIT | Scripps-Miles, Inc. | 1981-09-23 | 26 | 0 |
| K812489 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG | Dako Corp. | 1981-09-23 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda