FDA.reportPublic FDA data

HAI LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12265873003046678HAI LABORATORIES, INC.1N2026-01-01320 Massachusetts Ave LEXINGTON MA US 02420

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
570621854071418K994340CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZHLI2000-09-20
570621733742450K063433ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200IYO2007-01-29
570621426051401K033190VISION-TECH YZ SLIT LAMP, MODEL 66HJO2003-12-04
570621024714656
570621027069668
570621029165319
570621506644867
570621570721196
570621614034525
570621706317405
570621710728214
570621841077607
570621991696392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO12007-01-29
HJO12003-12-04
HLI12000-09-20

PMN#