BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003

Radioimmunoassay, Thyroid-stimulating Hormone

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Sensitive Tsh (s-tsh) Enzyme Immunoassay Test Kit; Catalog Number: Bc-1003.

Pre-market Notification Details

Device IDK990993
510k NumberK990993
Device Name:BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
ContactRobin Hellen
CorrespondentRobin Hellen
BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-24
Decision Date1999-06-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B24225TSHHUUE010 K990993 000
00840239017901 K990993 000
00850392007039 K990993 000
04048474017908 K990993 000

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