FDA.reportPublic FDA data

LABOTEK GROUP CORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101946213010194621LABOTEK GROUP CORP1Y2026-01-01CARR 174 KM 4.5 BO JUAN SANCHEZ Bayamon PR US 00956

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850014448134VACSURE Uni-Band - VACSURE Uni-Band, Universal bandage, 28 x 15 mm pad size, 19 x 38 mm overall size, Individually wrapped7877851555e.colon@labotekgroup.com
00850014448158Labotek Spot Bandage - Labotek Spot Bandage, 25 mm overall size, Ventilated, Individually wrapped7877851555e.colon@labotekgroup.com
00850014448172TOUCH Chemo Tested Nitrile Exam Glove - TOUCH Nitrile Examination Glove, Chemotherapy Tested, Size X-Small7877851555e.colon@labotekgroup.com
00850014448196TOUCH Chemo Tested Nitrile Exam Glove - TOUCH Nitrile Exam Glove, Chemotherapy Tested, Size Small7877851555e.colon@labotekgroup.com
00850014448332VACSURE Disposable Tourniquets - "VACSURE Disposable Tourniquets, TPE Material, 1"" x 18"" Pre-Notched"7877851555e.colon@labotekgroup.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1579621925304265K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMK2022-10-03
1579622059132311K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for SingleJKA2021-11-04
1579621830832726K180984Maxcon Sharps ContainerMMK2019-01-03
1579621810980205K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsLZA2017-08-25
1579621444368335K151991
1579621017312218
1579621022168575
1579621030597290
1579621038717795
1579621057872104
1579621057880448
1579621096706324
1579621105478621
1579621113634792
1579621124494337
1579621165897799
1579621169468959
1579621181890197
1579621215687407
1579621244169927
1579621282772986
1579621283323090
1579621289467640
1579621334781251
1579621360036808
1579621368287470
1579621371795744
1579621405326797
1579621417857173
1579621428305591
1579621430821684
1579621480516058
1579621504908846
1579621511411946
1579621511508318
1579621515862453
1579621526433446
1579621597839077
1579621636004270
1579621641272805
1579621652867670
1579621658034201
1579621664223182
1579621671230658
1579621744733147
1579621754688879
1579621772991835
1579621875041000
1579621925601853
1579621932543177
1579621959571344
1579621966231054
1579621987540165
1579622006591189
1579622030548533
1579622044895968

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMK12022-10-03
JKA12021-11-04
MMK12019-01-03
LZA12017-08-25

GUDID#