REAGENT, T-3 UPTAKE— 510(k) K770738

Name: FDA 510(k) clearance K770738
Creator: U.S. Food and Drug Administration
Published: 1977-06-22

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K770738 for REAGENT, T-3 UPTAKE, Substantially Equivalent on 1977-06-22. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1977-04-21
Decision date: 1977-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDP

view all

K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)2000-10-05
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10051999-06-02
K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

More clearances from G.D. Searle and Co.

view all

K821159 — IN-LINE OXYGEN MONITORING SYSTEM1982-05-25
K811068 — BYPASS COIL1981-05-27
K811071 — VENOUS OXYGEN PROBE1981-05-05
K803238 — INTRAVASCULAR CATHETER1981-04-23
K810630 — SILICONE ELASTOMER COATED LATEX FOLEY1981-03-31

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.