FDA.reportPublic FDA data

SCITECK Diagnostics

Matched from indexed company URL: Sciteck Diagnostics, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048758403004875840SCITECK Diagnostics1N2026-01-01317 Rutledge Road Fletcher NC US 28732

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
00854080008629AutoUA® - 200-60800-749-4537info@sciteck.org
00854080008643AutoUA® - 217-S800-749-4537Info@sciteck.org
00854080008650AutoUA® - 200-120800-749-4537Info@sciteck.org

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1881241012758413K970087CR PERFECTCGX1997-03-06
1881241794051799K954514UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINEKQO1996-06-21
1881241193978488K951877AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINEKQO1996-05-14
1881241170704607K950142CR PERFECTCGX1995-05-25
1881241513990929K940768AD PERFECTIFT1995-02-17
1881241814305269K935408UA PERFECTKQO1994-06-13
1881241295413544

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KQO31996-06-21
CGX21997-03-06
IFT11995-02-17

GUDID#