ALPCO/MERCODIA INSULIN ELISA— 510(k) K963911

Name: FDA 510(k) clearance K963911
Creator: U.S. Food and Drug Administration
Published: 1996-11-01

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K963911 for ALPCO/MERCODIA INSULIN ELISA, Substantially Equivalent on 1996-11-01. Applicant: American Laboratory Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1996-09-30
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFP

view all

K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY1995-09-25
K920109 — IMX INSULIN1992-05-07
K914820 — DSL INSULIN RIA (DSL 1600)1992-01-09
K903628 — AIA-PACK IRI1990-09-07
K901135 — ENZYMUN TEST(R) INSULIN1990-04-03

More clearances from American Laboratory Products Co., Ltd.

view all

K012576 — CIC-C1Q EIA2002-01-29
K011415 — ALPCO MILENIA ANTI-TG EIA2001-05-30
K011201 — ALPCO MILENIA ANTI-TPO ELISA2001-05-24
K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA1998-02-17
K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA1998-02-17

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