Atlas FDA

ACCUWELL T4-EIA

FDA 510(k) clearance K972974 · decided 1997-10-06

Clearance details

K-number
K972974
Device name
ACCUWELL T4-EIA
Applicant
Neometrics, Inc.
Decision
Substantially Equivalent
Date received
1997-08-11
Decision date
1997-10-06
Days to decision
56 days
Clearance type
Traditional
Product code
KLI
Device class
2
Regulation number
862.1700
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
E. Northport, NY, US
Third-party review
No
Expedited review
No

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ACCESS TOTAL T4 ASSAY (K023369)Beckman Coulter, Inc.2002-12-09
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (K001603)Repromedix Corp.2000-10-05
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (K000600)Syva Co., Dade Behring, Inc.2000-03-27
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (K991432)Biocheck, Inc.1999-06-02
OPTICOAT T4 EIA KIT (K982298)Biotecx Laboratories, Inc.1999-02-03
ABBOTT ARCHITECT TOTAL T4 (K983440)Abbott Laboratories1998-11-25
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Recalls involving this device

No recalls on record reference this clearance.