Atlas FDA

AFFINITY TOTAL THYROXINE IMMUNIT

FDA 510(k) clearance K873518 · decided 1987-10-29

Clearance details

K-number
K873518
Device name
AFFINITY TOTAL THYROXINE IMMUNIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1987-09-01
Decision date
1987-10-29
Days to decision
58 days
Clearance type
Traditional
Product code
KLI
Device class
2
Regulation number
862.1700
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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RecordFirmDate
VITROS® Automation Solutions (K160495)Ortho-Clinical Diagnostics, Inc.2016-10-18
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515)Alfa Wassermann2013-08-14
GSP NEONATAL THYROXINE (T4) (K103484)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2011-04-22
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638)Siemens Healthcare Diagnostics, Inc.2009-02-26
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.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05