IMMUCHEM COVALENT COAT SOLID PHASE ASSAY— 510(k) K791663

Name: FDA 510(k) clearance K791663
Creator: U.S. Food and Drug Administration
Published: 1979-10-01

Substantially Equivalent

Immuchem Corp.

FDA 510(k) clearance K791663 for IMMUCHEM COVALENT COAT SOLID PHASE ASSAY, Substantially Equivalent on 1979-10-01. Applicant: Immuchem Corp.. Device class: 2.

Clearance details

Applicant: Immuchem Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1979-08-21
Decision date: 1979-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

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K871542 — HPROLACTIN KIT1987-05-14
K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT1987-03-13
K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT1986-11-24

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.