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

Miles Laboratories, Inc. — Predicate Candidate Screening

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

38 daysmedian FDA review time
109 days90th percentile
158clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERMiles Laboratories, Inc.1988-05-261040
K874909MICRO-BUMINTEST REAGENT TABLETSMiles Laboratories, Inc.1988-04-281490
K875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEMiles Laboratories, Inc.1988-04-051180
K871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTMiles Laboratories, Inc.1987-12-222250
K872120SERALYZER III BLOOD CHEMISTRY ANALYZERMiles Laboratories, Inc.1987-10-281490
K873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)Miles Laboratories, Inc.1987-09-11240
K872634CUTTER PUREFLO PLUS IV FILTERMiles Laboratories, Inc.1987-08-04290
K870214MODIFIED SALTEX REAGENT STRIPSMiles Laboratories, Inc.1987-06-291600
K870752SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPSMiles Laboratories, Inc.1987-04-14480
K865053SERA-TEK MICROSOMAL ANTIBODY TESTMiles Laboratories, Inc.1987-02-18560
K864530SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.Miles Laboratories, Inc.1987-02-18930
K865020SERA-TEK THYROGLOBULIN ANTIBODY TESTMiles Laboratories, Inc.1987-02-02410
K863842SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONTMiles Laboratories, Inc.1987-01-141050
K861844GLUCOFACTS DATA MANAGEMENT SYSTEMMiles Laboratories, Inc.1986-08-12910
K861779GLUCOFACTS DATA PRINTERMiles Laboratories, Inc.1986-08-08920
K861303GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETERMiles Laboratories, Inc.1986-07-02860
K861778CLINIFACTS 200 DATA MANAGEMENT SYSTEMMiles Laboratories, Inc.1986-07-02550
K855202GLUCOMETER M BLOOD GULCOSE METERMiles Laboratories, Inc.1986-07-021880
K855203GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOODMiles Laboratories, Inc.1986-02-11470
K855040SERALYZER TOTAL BILIRUBIN CALIBRATORSMiles Laboratories, Inc.1986-01-22360
K852946SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLTMiles Laboratories, Inc.1985-09-30810
K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.1985-09-03760
K851703GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOTMiles Laboratories, Inc.1985-08-231210
K852747VISIDEX II REAGENT STRIPSMiles Laboratories, Inc.1985-08-12460
K853021OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.1985-08-07200
K852117CYTO-TEK CENTRIFUGEMiles Laboratories, Inc.1985-06-10260
K844955SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &Miles Laboratories, Inc.1985-03-19880
K842092SERALYZER ARIS PHENYTOIN REAGENT STRIPSMiles Laboratories, Inc.1985-03-192990
K844907CLINIFACTS 10 DATA MANAGEMENT SYSTEMMiles Laboratories, Inc.1985-01-18320
K843727LEUKOSTIX REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.1985-01-041020
K842470TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZMMiles Laboratories, Inc.1984-08-28640
K842468TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGGMiles Laboratories, Inc.1984-08-28640
K841041CLINI-TEK AUTO 2000 REFLECTANCE SPECTRMiles Laboratories, Inc.1984-08-241650
K842592AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.1984-08-17450
K842237CLINITEK 200 SEMI-AUTOMATED URINALYSISMiles Laboratories, Inc.1984-08-15710
K842238CLINITEK 10 SEMI-AUTO URINALYSIS SYSMiles Laboratories, Inc.1984-07-25500
K842006CITOJECT CARTRIDGE SYRINGEMiles Laboratories, Inc.1984-07-16600
K841814OPTIMATE IGM TESTMiles Laboratories, Inc.1984-06-22520
K841816OPTIMATE IGG TESTMiles Laboratories, Inc.1984-06-22520
K841815OPTIMATE IGA TESTMiles Laboratories, Inc.1984-06-01310
K841582OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.1984-05-11240
K832825SERALYZER THEOPHYLLINE REAGENT STRIPSMiles Laboratories, Inc.1984-03-192130
K833977SERALYZER DRUG ASSAY CONTROL SERUMMiles Laboratories, Inc.1984-03-191230
K832088AMES TDA NETILMICIN TEST & SERUMMiles Laboratories, Inc.1983-10-281220
K832791SERAYZER ALT/SGPT REAGENT STRIPSMiles Laboratories, Inc.1983-10-14560
K832790SERALYZER AST/SGOT REAGENT STRIPSMiles Laboratories, Inc.1983-10-14590
K832684SERALYZER TRIGLYCERIDES REAGENT STRIPSMiles Laboratories, Inc.1983-10-04560
K832766AMES TDA DISOPYRAMIDE TESTMiles Laboratories, Inc.1983-09-29440
K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.1983-09-29440
K832769AMES TDA KANAMYCIN TEST-CONTROL SERUMMiles Laboratories, Inc.1983-09-29440

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