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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL | Creative Laboratory Products, Inc. | 1995-03-20 | 39 | 0 |
| K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET | Creative Laboratory Products, Inc. | 1994-08-26 | 107 | 0 |
| K922995 | LIPID CONTROLS | Creative Laboratory Products, Inc. | 1992-08-12 | 51 | 0 |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Creative Laboratory Products, Inc. | 1991-11-19 | 110 | 0 |
| K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | Creative Laboratory Products, Inc. | 1991-11-08 | 102 | 0 |
| K913585 | LIPASE LINEARITY CONTROL | Creative Laboratory Products, Inc. | 1991-10-21 | 70 | 0 |
| K913224 | LIPID LINEARITY CONTROLS | Creative Laboratory Products, Inc. | 1991-09-25 | 68 | 0 |
| K913496 | CHOLINESTERASE LINEARITY CONTROL | Creative Laboratory Products, Inc. | 1991-09-11 | 36 | 0 |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | Creative Laboratory Products, Inc. | 1991-08-16 | 51 | 0 |
| K912725 | TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL | Creative Laboratory Products, Inc. | 1991-07-30 | 40 | 0 |
| K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II | Creative Laboratory Products, Inc. | 1991-01-23 | 77 | 0 |
| K902909 | CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL | Creative Laboratory Products, Inc. | 1990-08-22 | 50 | 0 |
| K896465 | CLP CK/LD ISOENZYME/IMMUNO CONTROL | Creative Laboratory Products, Inc. | 1990-03-01 | 108 | 0 |
| K895858 | CLP ELEVATED LIPID CONTROL | Creative Laboratory Products, Inc. | 1990-01-26 | 115 | 0 |
| K895862 | CLP NORMAL LIPID CONTROL | Creative Laboratory Products, Inc. | 1990-01-19 | 108 | 0 |
| K896246 | CLP COMPREHENSIVE LIPID CONTROL-LR | Creative Laboratory Products, Inc. | 1990-01-10 | 72 | 0 |
| K896247 | CLP COMPREHENSIVE LIPID CONTROL-HR | Creative Laboratory Products, Inc. | 1990-01-10 | 72 | 0 |
| K896334 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER | Creative Laboratory Products, Inc. | 1989-12-11 | 38 | 0 |
| K896335 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR | Creative Laboratory Products, Inc. | 1989-12-11 | 38 | 0 |
| K894554 | CLP CK/LD ISOENZYME CONTROL | Creative Laboratory Products, Inc. | 1989-10-16 | 88 | 0 |
| K881113 | CLP LIPOPROTEIN ELECTROPHORESIS CONTROL | Creative Laboratory Products, Inc. | 1988-07-01 | 108 | 0 |
| K880712 | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 | 74 | 0 |
| K881510 | CLP ABNORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 | 25 | 0 |
| K881068 | CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | Creative Laboratory Products, Inc. | 1988-03-23 | 9 | 0 |
| K880566 | CLP PROTHROMBIN TIME TEST | Creative Laboratory Products, Inc. | 1988-03-23 | 42 | 0 |
| K880711 | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. | Creative Laboratory Products, Inc. | 1988-03-18 | 25 | 0 |
| K880713 | CLP 0.1 M SODIUM CITRATE SOLUTION | Creative Laboratory Products, Inc. | 1988-03-18 | 25 | 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