Labotek Group Corp

FDA Filings

This page includes the latest FDA filings for Labotek Group Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010194621
• FEI Number: 3010194621
• Name: LABOTEK GROUP CORP
• Owner & Operator: LABOTEK GROUP CORP
• Contact Address: CARR 174 KM 4.5 BO JUAN SANCHEZ ; Bayamon PR 00956 US
• Official Correspondent:
  • MARISOL AROCHO
  • x-787-7851522-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: CARR 174 KM 4.5 BO JUAN SANCHEZ ; Bayamon, PR 00956 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Remanufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850014448462 LABOTEK GROUP CORP	VacSure EZ Care Pressure Activate Safety Lancet	2024-12-11
GUDID 00850014448431 LABOTEK GROUP CORP	VacSure EZ Care Pressure Activate Safety Lancet	2024-12-11
GUDID 10850014448384 LABOTEK GROUP CORP	VACSURE Sharp Container	2024-03-26
GUDID 10850014448377 LABOTEK GROUP CORP	VACSURE Sharp Container	2024-03-26
GUDID 10850014448360 LABOTEK GROUP CORP	VACSURE Sharp Container	2024-03-26
GUDID 10850014448353 LABOTEK GROUP CORP	VACSURE Sharp Container	2024-03-26
GUDID 10850014448346 LABOTEK GROUP CORP	VACSURE Sharp Container	2024-03-26
GUDID 10850014448339 LABOTEK GROUP CORP	VACSURE Disposable Tourniquets	2024-03-26
GUDID 00850014448264 LABOTEK GROUP CORP	TOUCH Chemo Tested Nitrile Exam Glove	2024-03-26
GUDID 00850014448240 LABOTEK GROUP CORP	TOUCH Chemo Tested Nitrile Exam Glove	2024-03-26
GUDID 00850014448226 LABOTEK GROUP CORP	TOUCH Chemo Tested Nitrile Exam Glove	2024-03-26
GUDID 00850014448202 LABOTEK GROUP CORP	TOUCH Chemo Tested Nitrile Exam Glove	2024-03-26
GUDID 00850014448189 LABOTEK GROUP CORP	TOUCH Chemo Tested Nitrile Exam Glove	2024-03-26
GUDID 00850014448165 LABOTEK GROUP CORP	Labotek Spot Bandage	2024-03-26
GUDID 00850014448141 LABOTEK GROUP CORP	VACSURE Uni-Band	2024-03-26
GUDID 00850014448035 LABOTEK GROUP CORP	VACSURE SAFETY MULTI-SAMPLE NEEDLE22G X 1 1/4", W/ PREMOUNTED HOLDER VM-1022-AH	2021-02-01
GUDID 00850014448028 LABOTEK GROUP CORP	VACSURE SAFETY MULTI-SAMPLE NEEDLE, 21G X 1 1/4" W/PREMOUNTED HOLDER VM-1021-AH	2021-02-01
GUDID 00850014448011 LABOTEK GROUP CORP	VACSURE SAFETY MULTI-SAMPLE NEEDLE ONLY , 22G X 1 1/4" VM-1022	2021-02-01
GUDID 00850014448004 LABOTEK GROUP CORP	VACSURE SAFETY MULTI-SAMPLE NEEDLE VM-1021	2021-02-01
LTG Alcohol Prep Pads Labotek Group Corp	Otc Medication	2020-12-31
NDC 81264-001 Labotek Group Corp	LTG Alcohol Prep Pads	2020-12-18
PER LABOTEK GROUP CORP	LABOTEK	2019-09-26
NNL LABOTEK GROUP CORP	LABOTEK	2019-09-26
NNI LABOTEK GROUP CORP	LABOTEK	2019-09-26
MPQ LABOTEK GROUP CORP	LABOTEK	2019-09-26
LXG LABOTEK GROUP CORP	LABOTEK	2019-09-26
LJX LABOTEK GROUP CORP	LABOTEK	2019-09-26
LDY LABOTEK GROUP CORP	LABOTEK	2019-09-26
KST LABOTEK GROUP CORP	LABOTEK	2019-09-26
KJG LABOTEK GROUP CORP	LABOTEK	2019-09-26
KJC LABOTEK GROUP CORP	LABOTEK	2019-09-26
KIZ LABOTEK GROUP CORP	LABOTEK	2019-09-26
KIW LABOTEK GROUP CORP	LABOTEK	2019-09-26
KIR LABOTEK GROUP CORP	LABOTEK	2019-09-26
KIQ LABOTEK GROUP CORP	LABOTEK	2019-09-26
KFL LABOTEK GROUP CORP	LABOTEK	2019-09-26
KEW LABOTEK GROUP CORP	LABOTEK	2019-09-26
KET LABOTEK GROUP CORP	LABOTEK	2019-09-26
KES LABOTEK GROUP CORP	LABOTEK	2019-09-26
KEI LABOTEK GROUP CORP	LABOTEK	2019-09-26
KDX LABOTEK GROUP CORP	LABOTEK	2019-09-26
KDW LABOTEK GROUP CORP	LABOTEK	2019-09-26
KDT LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRQ LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRO LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRJ LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRI LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRC LABOTEK GROUP CORP	LABOTEK	2019-09-26
JRB LABOTEK GROUP CORP	LABOTEK	2019-09-26
JQW LABOTEK GROUP CORP	LABOTEK	2019-09-26
JPH LABOTEK GROUP CORP	LABOTEK	2019-09-26
JJG LABOTEK GROUP CORP	LABOTEK	2019-09-26
JJF LABOTEK GROUP CORP	LABOTEK	2019-09-26
IQG LABOTEK GROUP CORP	LABOTEK	2019-09-26
IGG LABOTEK GROUP CORP	LABOTEK	2019-09-26
IFP LABOTEK GROUP CORP	LABOTEK	2019-09-26
IDZ LABOTEK GROUP CORP	LABOTEK	2019-09-26
IDO LABOTEK GROUP CORP	LABOTEK	2019-09-26
IDM LABOTEK GROUP CORP	LABOTEK	2019-09-26
GLG LABOTEK GROUP CORP	LABOTEK	2019-09-26
GLE LABOTEK GROUP CORP	LABOTEK	2019-09-26
GKQ LABOTEK GROUP CORP	LABOTEK	2019-09-26
GKM LABOTEK GROUP CORP	LABOTEK	2019-09-26
GJW LABOTEK GROUP CORP	LABOTEK	2019-09-26
GJG LABOTEK GROUP CORP	LABOTEK	2019-09-26
GIO LABOTEK GROUP CORP	LABOTEK	2019-09-26
GHO LABOTEK GROUP CORP	LABOTEK	2019-09-26
GHC LABOTEK GROUP CORP	LABOTEK	2019-09-26
GGY LABOTEK GROUP CORP	LABOTEK	2019-09-26
DGR LABOTEK GROUP CORP	LABOTEK	2019-09-26
PMN K151991 | FPA LABOTEK GROUP CORP	Vacsure Safety Blood Collection Set 1	2019-09-25

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091976770	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	PREPAD PACKAGE MACHINE	1 PKG
2020091558437	Ningpo ,China (Mainland) -> San Juan, Puerto Rico	SHARPS CONTAINER	1804 CTN
2020091558437	Ningpo ,China (Mainland) -> San Juan, Puerto Rico	SHARPS CONTAINER	1804 CTN
2020091558437	Ningpo ,China (Mainland) -> San Juan, Puerto Rico	SHARPS CONTAINER	1804 CTN
2020090922496	Port Bustamante,Jamaica -> San Juan, Puerto Rico	PLASTIC DISPOSAL LABWARE HTS 39269097	754 BOX
2020090820450	Port Bustamante,Jamaica -> San Juan, Puerto Rico	IRRIGATIONTRAYPISTON - IRRIGATION TRAY BULB I RRIGATION TRAY PISTON	1130 CTN
2020072810074	Pusan,South Korea -> San Juan, Puerto Rico	PLASTIC SHIELD	75 CTN
2020071020102	Port Bustamante,Jamaica -> San Juan, Puerto Rico	PLASTIC DISPOSAL LABWARE HTS 39269097	984 BOX
202003231043	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	BLOOD COLLECTION NEEDLE	695 CTN
2020031751727	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S	120 PKG