AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM— 510(k) K791375

Name: FDA 510(k) clearance K791375
Creator: U.S. Food and Drug Administration
Published: 1979-10-11

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K791375 for AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM, Substantially Equivalent on 1979-10-11. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant: Micromedic Systems
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1979-07-24
Decision date: 1979-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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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 Micromedic Systems

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K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26
K871008 — MICROMEDIC NEONATAL T4 KIT1987-05-26
K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26

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.