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FDA 510(k)

IBL C1Q-CIC CIA TEST

K-Number: K032254 · 2003-08-29

ApplicantIbl GmbH
Decision Date2003-08-29
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IBL C1Q-CIC CIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ibl GmbH. It received FDA 510(k) clearance on 2003-08-29 under 510(k) number K032254. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBL C1Q-CIC CIA TEST?

IBL C1Q-CIC CIA TEST is a medical device that received FDA 510(k) clearance on 2003-08-29. The listed applicant is Ibl GmbH. The 510(k) number is K032254.

When did IBL C1Q-CIC CIA TEST receive FDA 510(k) clearance?

IBL C1Q-CIC CIA TEST received FDA 510(k) clearance on 2003-08-29, under 510(k) number K032254.

Who is the listed applicant for IBL C1Q-CIC CIA TEST?

The FDA 510(k) record lists Ibl GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBL C1Q-CIC CIA TEST?

The FDA product code for IBL C1Q-CIC CIA TEST is DAK.

Other records listing Ibl GmbH 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.

K051969TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIAK041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMK040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAK033786LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVAK032796IBL C3D-CIC EIA TEST

Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K914388C1 RID KITThe Binding Site, Ltd.

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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