Atlas FDA

IMMUBEAD T4 ENZYME IMMUNOASSAY KIT

FDA 510(k) clearance K872192 · decided 1987-08-13

Clearance details

K-number
K872192
Device name
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
Applicant
Immunotech Corp.
Decision
Substantially Equivalent
Date received
1987-06-08
Decision date
1987-08-13
Days to decision
66 days
Clearance type
Traditional
Product code
KLI
Device class
2
Regulation number
862.1700
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Boston, MA, US
Third-party review
No
Expedited review
No

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ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860)Monobind2003-08-22
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
ACE T4 REAGENT T4 CALIBRATORS (K981377)Schiapparelli Biosystems, Inc.1998-06-10

Recalls involving this device

No recalls on record reference this clearance.