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FDA 510(k)

AMIKACIN RIA KIT

K-Number: K802877 · 1980-12-19

ApplicantAntibodies, Inc.
Decision Date1980-12-19
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMIKACIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Antibodies, Inc.. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802877. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIKACIN RIA KIT?

AMIKACIN RIA KIT is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Antibodies, Inc.. The 510(k) number is K802877.

When did AMIKACIN RIA KIT receive FDA 510(k) clearance?

AMIKACIN RIA KIT received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802877.

Who is the listed applicant for AMIKACIN RIA KIT?

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

What is the FDA product code for AMIKACIN RIA KIT?

The FDA product code for AMIKACIN RIA KIT is KLQ.

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Other records listing Antibodies, Inc. 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.

K890774GIARDEIA(TM)K843590DETECT-A-STREPK822892CORTISOL RIA KITK812749ULTRA-DIGK812314CRITHIDNA ANTI-DNA TEST KITK800743TOBRAMYCIN RIA KIT

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Related Devices (Code: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, Inc.

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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