PCP DIRECT RIA KIT (I-125)— 510(k) K913864

Name: FDA 510(k) clearance K913864
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K913864 for PCP DIRECT RIA KIT (I-125), Substantially Equivalent on 1991-10-11. Applicant: Immunalysis Corporation. Device class: Unclassified.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code LCL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1991-08-27
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCL

view all

K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY2002-02-11
K994093 — AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C1999-12-16
K890882 — ABUSCREEN FP FOR PHENCYCLIDINE1989-03-15
K882179 — EMIT HVA PHENCYCLIDINE ASSAY1988-07-12
K880011 — REVISED LABELING FOR ADX PHENCYCLIDINE1988-02-11

More clearances from Immunalysis Corporation

view all

K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K232898 — Quantisal Oral Fluid Collection Device2023-11-21
K223781 — Quantisal II Oral Fluid Collection Device2023-07-28
K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay2021-12-22
K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay2021-12-22

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