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

Ventrex Laboratories, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
102 days90th percentile
82clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K914554SPECIFIC IGE EIA-TURBO ASSAYVentrex Laboratories, Inc.1992-03-131540
K913833VENTREX ALLERGEN DISCVentrex Laboratories, Inc.1992-02-211790
K913434VENTREX COATED TUBE INTACT PTHVentrex Laboratories, Inc.1991-10-25850
K905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYVentrex Laboratories, Inc.1991-02-21690
K905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYVentrex Laboratories, Inc.1991-02-07520
K905247SHBG IRMA KITVentrex Laboratories, Inc.1991-01-17570
K904330TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.1990-12-07780
K903000TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.1990-07-31220
K897083VENTRESIGN STREP A TESTVentrex Laboratories, Inc.1990-01-22330
K895648COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.Ventrex Laboratories, Inc.1990-01-181200
K895649COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.Ventrex Laboratories, Inc.1990-01-181200
K896852VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYVentrex Laboratories, Inc.1989-12-18130
K896694VENTREZYME VAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.1989-12-08100
K891068VENTREX COATED TUBE T3 UPTAKEVentrex Laboratories, Inc.1989-04-10400
K890549VENTREX COATED TUBE HCGVentrex Laboratories, Inc.1989-03-28530
K885157VENTREX COATED TUBE HIGH SENSITIVITY TSHVentrex Laboratories, Inc.1989-02-10590
K883342VENTREX COATED TUBE TSHVentrex Laboratories, Inc.1988-09-13350
K880678MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAYVentrex Laboratories, Inc.1988-04-05460
K880547VENTREZYME VAST IMMUNO-PEROXIDASE ASSAYVentrex Laboratories, Inc.1988-03-25450
K874258VENTRESCREEN, HCG URINEVentrex Laboratories, Inc.1987-11-23340
K873647VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBEVentrex Laboratories, Inc.1987-10-20410
K872032VENTRESCREEN (TM) MONOVentrex Laboratories, Inc.1987-06-29330
K871331VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.Ventrex Laboratories, Inc.1987-04-28250
K870009VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.Ventrex Laboratories, Inc.1987-04-141020
K870876HL-1 SUPPLEMENTVentrex Laboratories, Inc.1987-03-31280
K870624VENTREX IP SPECIFIC E ENZYME IMMUNOASSAYVentrex Laboratories, Inc.1987-03-24390
K862901VENTRESCREEN II POLLENS ENZYME IMMUNOASSAYVentrex Laboratories, Inc.1986-09-16470
K861919VENTREX APO BVentrex Laboratories, Inc.1986-06-06180
K850895VENTREZYME, VAST IMMUNOPEROXIDASE ASSAYVentrex Laboratories, Inc.1985-10-162260
K851403VENTREZYME ALLERGEN DATA REDUCTION SYSTEMVentrex Laboratories, Inc.1985-06-21730
K844855VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.1985-01-16330
K843230VENTREZYME PAP KIT IMMUNOASSAY PROSTATICVentrex Laboratories, Inc.1984-09-04180
K842264VENTREZYME PHENOBARBITAL KIT IMMUNOVentrex Laboratories, Inc.1984-08-14680
K842161VENTREZYME PHENYTOIN KIT IMMUNOASSAYVentrex Laboratories, Inc.1984-07-09400
K842239VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.1984-07-02270
K841993HL-1, DEFINED SERUM FREE MEDIAVentrex Laboratories, Inc.1984-06-25410
K841651VAST VENTREX RAST ALLVentrex Laboratories, Inc.1984-06-01420
K840830VENTRIA APO A-1 ALPHA-1 LIPOTROTEINVentrex Laboratories, Inc.1984-05-21870
K841516VENTRESCREEN, MULTIPLE ALLERGEN DISCSVentrex Laboratories, Inc.1984-05-11290
K841024VENTREZYME T4U IMMUNOASSAY T4UVentrex Laboratories, Inc.1984-05-09580
K841081VENTREZYME BETA-HCG IMMUNOASSAY HCGVentrex Laboratories, Inc.1984-05-07550
K841023COATED TUBE HCG IMMUNOASSAY HCGVentrex Laboratories, Inc.1984-05-01500
K833423VENTREZYME EIA CONTROLS-IMMUNOASSAYVentrex Laboratories, Inc.1983-12-08660
K832217VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOODVentrex Laboratories, Inc.1983-09-201040
K832218ALLERGEN CONTROL INHALENTVentrex Laboratories, Inc.1983-09-201040
K831554NEIN ALLERGEN DISC IN VAST VENTREX TESTVentrex Laboratories, Inc.1983-06-08260
K831485VENTRE/ZYME IGE KITVentrex Laboratories, Inc.1983-06-02240
K830928VENTREX ENZYME TSH KITVentrex Laboratories, Inc.1983-04-28360
K831091NEW ALLERGEN DISC -VAST VENTEX ALLERGYVentrex Laboratories, Inc.1983-04-27230
K830817NEW ALLERGEN DISCS FOR USE IN VAST VENTVentrex Laboratories, Inc.1983-04-27430

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