510(k) K023369
- Device
- ACCESS TOTAL T4 ASSAY
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K023369
- Product code
- KLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-09
- Date received
- 2002-10-08
- Regulation
- 862.1700
- Classification name
- Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENISE THOMPSON
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3005094123
- 3006198300
- 3050015
- 3009984016
- 3002800697
- 3003795116
- 3003030793
- 2050012
- 8043909
- 2245285
- 9615037
- 3005333358
- 2432235
- 9610529
- 3022178699
- 3012963943
- 2250051
- 1832216
- 3010939897
- 3002809144
- 9612316
- 1181055
- 2020726
- 1222302
- 3009518015
- 1036362
- 2517506
- 2247288
- 2122870
- 8031673
- 1827821
- 2032682
- 3002642396
- 3005984081
- 2050010
- 3010825766
- 3014325803
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000308930
- 3002806944
Source Documents#
Other 510(k) Records For Product Code KLI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 |
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | Alfa Wassermann | 2013-08-14 |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 |
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Monobind | 2003-08-22 |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | 2000-10-05 |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | Syva Co., Dade Behring, Inc. | 2000-03-27 |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | Biocheck, Inc. | 1999-06-02 |
| K982298 | OPTICOAT T4 EIA KIT | Biotecx Laboratories, Inc. | 1999-02-03 |
| K983440 | ABBOTT ARCHITECT TOTAL T4 | Abbott Laboratories | 1998-11-25 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | 1997-10-06 |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Monobind | 1997-06-16 |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | Beckman Instruments, Inc. | 1997-05-16 |
Legacy Summary#
summary
FDA Review#
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