510(k) K932980
- Device
- TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K932980
- Product code
- CDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-18
- Date received
- 1993-06-17
- Regulation
- 862.1700
- Classification name
- Radioimmunoassay, Total Thyroxine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARRY ROBINS
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 3017019647
- 3009335633
- 9610126
- 2432235
- 3009984016
- 3002800697
- 2032839
- 3017379203
- 3017894300
- 8043909
- 2245285
- 3003741796
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CDX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961490 | ELECSYS T4 ASSAY | Boehringer Mannheim Corp. | 1996-06-13 |
| K954312 | ACTIVE THYROXINE RIA | Diagnostic Systems Laboratories, Inc. | 1995-10-07 |
| K943416 | DELFIA NEONATAL THYROXINE KIT | Wallac OY | 1995-03-10 |
| K934384 | AXSYM(TM) TOTAL T4 | Abbott Laboratories | 1994-06-21 |
| K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1993-08-26 |
| K931295 | IQ TT4 ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-20 |
| K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | Bio-Chem Laboratory Systems, Inc. | 1993-03-18 |
| K925110 | ABBOTT IMX T4 | Abbott Laboratories | 1993-01-26 |
| K925109 | ABBOTT TDX/TDXFLX TT4 | Abbott Laboratories | 1993-01-04 |
| K922945 | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | Heraeus Kulzer, Inc. | 1992-10-14 |
| K921935 | THYROXINE (T4) COATED TUBE RIA | Monobind | 1992-07-07 |
| K920766 | T4 EIA BEAD ASSAY | Tech-Co, Inc. | 1992-04-17 |
| K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | Incstar Corp. | 1992-01-28 |
| K912541 | MILENIA TOTAL T4, CATALOG: MKT41,5 | Diagnostic Products Corp. | 1991-08-12 |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | London Diagnostics, Inc. | 1991-08-02 |
Legacy Summary#
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FDA Review#
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