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FDA 510(k)

ALPCO/MERCODIA INSULIN ELISA

K-Number: K963911 · 1996-11-01

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1996-11-01
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALPCO/MERCODIA INSULIN ELISA is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963911. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPCO/MERCODIA INSULIN ELISA?

ALPCO/MERCODIA INSULIN ELISA is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K963911.

When did ALPCO/MERCODIA INSULIN ELISA receive FDA 510(k) clearance?

ALPCO/MERCODIA INSULIN ELISA received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963911.

Who is the listed applicant for ALPCO/MERCODIA INSULIN ELISA?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPCO/MERCODIA INSULIN ELISA?

The FDA product code for ALPCO/MERCODIA INSULIN ELISA is CFP.

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Other records listing American Laboratory Products Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012576CIC-C1Q EIAK011415ALPCO MILENIA ANTI-TG EIAK011201ALPCO MILENIA ANTI-TPO ELISAK974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAK974701ORGENTEC ANTI-MPO (P-ANCA) ELISAK972190THYROGLOBULIN ASSAY SYSTEM

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Related Devices (Code: CFP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.K896572REP(TM) SPE PLUS-30 PROCEDURESHelena Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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