FDA.reportPublic FDA data

BIOCHECK, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29537563002564473BIOCHECK, INC.1N2026-01-013451 Vincent Rd Pleasant Hill CA US 94523

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
00850392007015BioCheck TSH EIA Test Kit - The BioCheck TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.(650)573-1968info@biocheckinc.com
00850392007039BioCheck U-TSH EIA Test Kit - The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.(650)573-1968info@biocheckinc.com
00850392007053BioCheck T3 EIA Test Kit - The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum.(650)573-1968info@biocheckinc.com
00850392007077BioCheck T4 EIA Test Kit - The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum.(650)573-1968info@biocheckinc.com
00850392007176BioCheck Myoglobin EIA Test Kit - The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum.(650)573-1968info@biocheckinc.com
00850392007190BioCheck High Sensitive CRP EIA Test Kit - BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.(650)573-1968info@biocheckinc.com
00850392007251BioCheck Human Ferritin EIA Test Kit - The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin in human serum.(650)573-1968info@biocheckinc.com
00850392007275BioCheck hCG EIA Test Kit - The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum.(650)573-1968info@biocheckinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
547021718237483K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
547022035213302K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
547021320512917K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
547021198018982K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
547021981192628K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
547021094667589K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
547021473333970K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
547021596072103K111452PRESAGE ST2 ASSAYOYG2011-12-09
547021444745839K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19
547021074277417K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITMMI2002-01-08
547021829976657K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCK2001-07-20
547021009424818K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115CDZ2000-10-02
547021455015515K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061JZG2000-09-26
547021123382221DEN170045Banyan BTIQAT2018-02-14
547021157231985
547021164708359
547021169040820
547021222938225
547021287416598
547021827321584
547021932462632
547021569898188

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JLW21999-06-22
QAT12018-02-14
OYG12011-12-09
DRR12002-12-19
MMI12002-01-08
DCK12001-07-20
CDZ12000-10-02
JZG12000-09-26
DBF11999-09-24
DGC11999-09-21
JHI11999-07-22
CDP11999-06-02
KLI11999-06-02

PMN#

GUDID#