Atlas FDA

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

Amresco, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
108 days90th percentile
39clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905618GGT REAGENTAmresco, Inc.1991-02-26740
K904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176Amresco, Inc.1991-01-171080
K905684ALKALINE PHOSPHATASEAmresco, Inc.1990-12-2890
K905544MAGNESIUM REAGENTAmresco, Inc.1990-12-27160
K905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173Amresco, Inc.1990-12-11180
K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116Amresco, Inc.1990-12-111040
K905096GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138Amresco, Inc.1990-11-28150
K904381DIAZO COLORIMENTRY DIRECT BILIRUBINAmresco, Inc.1990-10-12160
K903775CREATINE PHOSPHOKINASEAmresco, Inc.1990-10-04450
K903829AST REAGENTAmresco, Inc.1990-09-25350
K904007BICARBONATE REAGENTS AMRESCO PRODUCT #4326020Amresco, Inc.1990-09-13150
K902476CALCIUM:ARSENAZO IIIAmresco, Inc.1990-07-17420
K902479CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432Amresco, Inc.1990-07-17420
K862300AMRESCO FLOW PAC SODIUM POTASSIUM REAGENTAmresco, Inc.1986-07-29420
K862299AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTSAmresco, Inc.1986-07-01140
K860664CRESOLPHTHALEIN COMPLEXONE, CALCIUMAmresco, Inc.1986-06-271230
K860663AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENTAmresco, Inc.1986-04-11460
K860662AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271Amresco, Inc.1986-03-14180
K860661AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENTAmresco, Inc.1986-03-14180
K860660AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmresco, Inc.1986-03-14180
K852948AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRIAmresco, Inc.1985-08-07270
K851923AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATEAmresco, Inc.1985-05-24220
K851865AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATEAmresco, Inc.1985-05-20210
K832438CHLORIDE REAGENT SETAmresco, Inc.1984-01-201790
K832439CREATININE REAGENT SETAmresco, Inc.1984-01-171760
K830959FLOW-PAC SGPT REAGENTAmresco, Inc.1983-05-04400
K830958FLOW-PAC SGOT REAGENTAmresco, Inc.1983-05-04400
K830957FLOW-PAC TRIGLYCERIDE REAGENTAmresco, Inc.1983-04-18240
K830537FLOW-PAC CREATININE REAGENT SETAmresco, Inc.1983-03-24340
K830535FLOW-PAC ALKALINE PHOSPHATE REAGENT SETAmresco, Inc.1983-03-24340
K830555AMRESCO UREA NITROGEN REAGENT SETAmresco, Inc.1983-03-24290
K830536FLOW-PAC ALBUMIN REAGENTAmresco, Inc.1983-03-24340
K830538FLOW-PAC TOTAL PROTEIN REAGENT SETAmresco, Inc.1983-03-24340
K823721FLOW-PAC LDH REAGENT SETAmresco, Inc.1983-01-09300
K823170LIQUIZYME TOTAL PROTEIN REAGENTAmresco, Inc.1982-11-29340
K813560LIQUIZYME CREATININE REAGENT SETAmresco, Inc.1982-01-29380
K812945LIQUILYME BUN REAGENTAmresco, Inc.1981-11-06170
K811592LIQUIZYME SINGLE SOLUTION GLUCOSE REAGAmresco, Inc.1981-07-01230
K803297LUQUIZYME TRIGLYCERIDE REAGENT SETAmresco, Inc.1981-01-16170

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