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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

King Diagnostics, Inc. — Predicate Candidate Screening

41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

60 daysmedian FDA review time
116 days90th percentile
41clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENKing Diagnostics, Inc.1993-10-221060
K931834KING SODIUM/POTASSIUM STANDARD MODIFIEDKing Diagnostics, Inc.1993-08-251520
K931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)King Diagnostics, Inc.1993-08-161290
K931326KING DIAGNOSTICS CK REAGENTKing Diagnostics, Inc.1993-06-15910
K923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTKing Diagnostics, Inc.1992-11-021290
K922969KING DIAGNOSTICS UREA NITROGEN REAGENTKing Diagnostics, Inc.1992-10-131160
K922921KING DIAGNOSTICS CHLORIDE REAGENTKing Diagnostics, Inc.1992-10-051100
K923927KING DIAGNOSTICS MAGNESIUM REAGENTKing Diagnostics, Inc.1992-09-30560
K923128KING DIAGNOSTICS CHOLESTEROL REAGENTKing Diagnostics, Inc.1992-09-09750
K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.1992-09-09760
K922964KING DIAGNOSTIC TRIGLYCERIDES REAGENTKing Diagnostics, Inc.1992-08-18600
K922835CALCIUM (AZ III) REAGENTKing Diagnostics, Inc.1992-08-04530
K922108KING DIAGNOSTICS AST (GOT) REAGENTKing Diagnostics, Inc.1992-07-15710
K922109KING DIAGNOSTICS ALT (GPT) REAGENTKing Diagnostics, Inc.1992-06-04300
K920809KING DIAGNOSTICS SODIUM/POTASSIUM STANDARDKing Diagnostics, Inc.1992-04-17560
K912499KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TESTKing Diagnostics, Inc.1991-09-271140
K912251KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TESTKing Diagnostics, Inc.1991-07-18580
K884485KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENTKing Diagnostics, Inc.1988-12-28640
K883635KD 0.1 M SODIUM CITRATE SOLUTIONKing Diagnostics, Inc.1988-10-31670
K883637KD 0.02 M CALCIUM CHLORIDE SOLUTIONKing Diagnostics, Inc.1988-10-31670
K883640KD ONE-STAGE PROTHROMBIN TIME TESTKing Diagnostics, Inc.1988-10-31670
K882220CALIBRATION KITKing Diagnostics, Inc.1988-08-02680
K873726ACID PHOSPHATASE TESTKing Diagnostics, Inc.1988-01-271340
K862498ALKALINE PHOSPHATASE TESTKing Diagnostics, Inc.1986-09-26870
K862306KING DIAGNOSTICS LDH TESTKing Diagnostics, Inc.1986-08-19630
K862208KING DIAGNOSTICS URIC ACID TESTKing Diagnostics, Inc.1986-07-08280
K831411GLUCOSE OXIDASE/PEROXIDASE TESTKing Diagnostics, Inc.1983-07-06650
K820418K.D. COLORIMETRIC BLOOD UREA N2 TESTKing Diagnostics, Inc.1982-03-11230
K812127KING DIAGNOSTICS HEMOGLOBIN TESTKing Diagnostics, Inc.1981-08-25290
K811882KING DIAGNOSTICS GLUCOSE TESTKing Diagnostics, Inc.1981-07-23220
K811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.1981-07-23220
K811881KING DIAGNOSTICS TOTAL BILIRUBIN TESTKing Diagnostics, Inc.1981-07-23220
K811746KING DIAGNOSTICS CHOLESTEROL-FE TESTKing Diagnostics, Inc.1981-07-10180
K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.1981-07-10180
K811749KING DIAGNOSTICS PHOSPHORUS TESTKing Diagnostics, Inc.1981-07-10180
K811748KING DIAGNOSTICS CALCIUM TESTKing Diagnostics, Inc.1981-07-10180
K811687URIC ACID TESTKing Diagnostics, Inc.1981-07-01160
K811673TOTAL PROTEIN TESTKing Diagnostics, Inc.1981-06-25100
K811664CREATININE TESTKing Diagnostics, Inc.1981-06-25100
K811662ALBUMIN TESTKing Diagnostics, Inc.1981-06-25100
K811661POTASSIUM TESTKing Diagnostics, Inc.1981-06-25100

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