GSP NEONATAL THYROXINE (T4)
FDA 510(k) clearance K103484 · decided 2011-04-22
Clearance details
- K-number
- K103484
- Device name
- GSP NEONATAL THYROXINE (T4)
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-26
- Decision date
- 2011-04-22
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VITROS® Automation Solutions (K160495) | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 |
| ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515) | Alfa Wassermann | 2013-08-14 |
| ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638) | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 |
| ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860) | Monobind | 2003-08-22 |
| 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 Laboratories | 1998-11-25 |
| ACE T4 REAGENT T4 CALIBRATORS (K981377) | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| ACCUWELL T4-EIA (K972974) | Neometrics, Inc. | 1997-10-06 |
Recalls involving this device
No recalls on record reference this clearance.