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

Creative Laboratory Products, Inc. — Predicate Candidate Screening

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

68 daysmedian FDA review time
108 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950589CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROLCreative Laboratory Products, Inc.1995-03-20390
K942284CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SETCreative Laboratory Products, Inc.1994-08-261070
K922995LIPID CONTROLSCreative Laboratory Products, Inc.1992-08-12510
K913427SICKLE HEMOGLOBIN (HBA/S) CONTROL SETCreative Laboratory Products, Inc.1991-11-191100
K913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CALCreative Laboratory Products, Inc.1991-11-081020
K913585LIPASE LINEARITY CONTROLCreative Laboratory Products, Inc.1991-10-21700
K913224LIPID LINEARITY CONTROLSCreative Laboratory Products, Inc.1991-09-25680
K913496CHOLINESTERASE LINEARITY CONTROLCreative Laboratory Products, Inc.1991-09-11360
K912823HIGH DENSITY LIPOPROTEIN CHOLESTEROLCreative Laboratory Products, Inc.1991-08-16510
K912725TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROLCreative Laboratory Products, Inc.1991-07-30400
K904989CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-IICreative Laboratory Products, Inc.1991-01-23770
K902909CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROLCreative Laboratory Products, Inc.1990-08-22500
K896465CLP CK/LD ISOENZYME/IMMUNO CONTROLCreative Laboratory Products, Inc.1990-03-011080
K895858CLP ELEVATED LIPID CONTROLCreative Laboratory Products, Inc.1990-01-261150
K895862CLP NORMAL LIPID CONTROLCreative Laboratory Products, Inc.1990-01-191080
K896246CLP COMPREHENSIVE LIPID CONTROL-LRCreative Laboratory Products, Inc.1990-01-10720
K896247CLP COMPREHENSIVE LIPID CONTROL-HRCreative Laboratory Products, Inc.1990-01-10720
K896334CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ERCreative Laboratory Products, Inc.1989-12-11380
K896335CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NRCreative Laboratory Products, Inc.1989-12-11380
K894554CLP CK/LD ISOENZYME CONTROLCreative Laboratory Products, Inc.1989-10-16880
K881113CLP LIPOPROTEIN ELECTROPHORESIS CONTROLCreative Laboratory Products, Inc.1988-07-011080
K880712CLP NORMAL COAGULATION CONTROLCreative Laboratory Products, Inc.1988-05-06740
K881510CLP ABNORMAL COAGULATION CONTROLCreative Laboratory Products, Inc.1988-05-06250
K881068CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTCreative Laboratory Products, Inc.1988-03-2390
K880566CLP PROTHROMBIN TIME TESTCreative Laboratory Products, Inc.1988-03-23420
K880711CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, Inc.1988-03-18250
K880713CLP 0.1 M SODIUM CITRATE SOLUTIONCreative Laboratory Products, Inc.1988-03-18250

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