Atlas FDA

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

Carolina Liquid Chemistries Corp. · Predicate Candidate Screening

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

25 daysmedian FDA review time
182 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite ECarolina Liquid Chemistries Corp.2022-01-271200
K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CARCarolina Liquid Chemistries Corp.2014-05-161820
K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTCarolina Liquid Chemistries Corp.2014-05-082520
K972073TOTAL BILIRUBIN REAGENTCarolina Liquid Chemistries Corp.1997-06-24210
K971907CALCIUM REAGENTCarolina Liquid Chemistries Corp.1997-06-24320
K971324TRIGLYCERIDES, TG, OR TRIGCarolina Liquid Chemistries Corp.1997-06-20710
K971908CREA OR CREATININECarolina Liquid Chemistries Corp.1997-06-17250
K971967BUNCarolina Liquid Chemistries Corp.1997-06-17200
K971467SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)Carolina Liquid Chemistries Corp.1997-06-16550
K971396CK REAGENTCarolina Liquid Chemistries Corp.1997-05-29440
K971345CHOL OR CHOLESTEROLCarolina Liquid Chemistries Corp.1997-05-29490
K971463ALP REAGENT SETCarolina Liquid Chemistries Corp.1997-05-16250
K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.1997-05-16180
K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.1997-05-06140
K971398LD-L REAGENTCarolina Liquid Chemistries Corp.1997-05-02170
K971445ALB OR ALBUMINCarolina Liquid Chemistries Corp.1997-05-02110
K971323ALT OR SGPTCarolina Liquid Chemistries Corp.1997-04-21110
K971363SYNCHRON CX SYSTEMS PHOSPHORUS REAGENTCarolina Liquid Chemistries Corp.1997-04-21140
K971344AST OR SGOTCarolina Liquid Chemistries Corp.1997-04-21110
K971133URIC, UA, OR URIC ACIDCarolina Liquid Chemistries Corp.1997-04-14180

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