CDP · Class II · 21 CFR 862.1710

FDA Product Code CDP: Radioimmunoassay, Total Triiodothyronine

Leading manufacturers include Abbott Laboratories, Diagnostic Products Corp. and Boehringer Mannheim Corp..

144

Total

144

Cleared

62d

Avg days

1976

Since

FDA 510(k) Cleared Radioimmunoassay, Total Triiodothyronine Devices (Product Code CDP)

144 devices

1–24 of 144

Cleared Nov 20, 1998

ABBOTT ARCHITECT TOTAL T3

ABBOTT ARCHITECT FREE T3

Diagnostic Products Corp.

Chemistry · 21d

Cleared Oct 31, 1997

ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K973966

Beckman Instruments, Inc.

Boehringer Mannheim Corp.

Boehringer Mannheim Corp.

Chemistry · 136d

Cleared Oct 30, 1996

AXSYM FREE TRIIODOTHYRONINE (FREE T3)

IMX FREE TRIIODOTHYRONINE (FREE T3)

Boehringer Mannheim Corp.

Roche Diagnostic Systems, Inc.

Chemistry · 189d

Cleared Oct 15, 1992

VISTA TRIIODOTHYRONINE ASSAY

KODAK AMERLEX MAB FT3 ASSAY

K922771

Eastman Kodak Company

Diagnostic Products Corp.

Chemistry · 122d

Cleared Jan 23, 1991

IMX FREE TRIIODOTHYRONINE

TDX FREE T3 CALCULATION

IMX FREE T3 CALCULATION

Boehringer Mannheim Corp.

Chemistry · 62d

Cleared Oct 31, 1989

ABBOTT TDX TOTAL T3 PLUS

MILENIA(TM) TOTAL T4 (MKT41,5)

K895840

Diagnostic Products Corp.

Chemistry · 16d

Cleared Oct 13, 1989

STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.

K894993

Baxter Healthcare Corp

Toxicology · 66d

Cleared Oct 25, 1988

STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME

K883479

Baxter Healthcare Corp

FDA Product Code CDP: Radioimmunoassay, Total Triiodothyronine

FDA 510(k) Cleared Radioimmunoassay, Total Triiodothyronine Devices (Product Code CDP)

About Product Code CDP - Regulatory Context

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