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FDA 510(k)

COAT-A-COUNT AMIKACIN IRA

K-Number: K820781 · 1982-04-09

ApplicantDiagnostic Products Corp.
Decision Date1982-04-09
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT AMIKACIN IRA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820781. 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 COAT-A-COUNT AMIKACIN IRA?

COAT-A-COUNT AMIKACIN IRA is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K820781.

When did COAT-A-COUNT AMIKACIN IRA receive FDA 510(k) clearance?

COAT-A-COUNT AMIKACIN IRA received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820781.

Who is the listed applicant for COAT-A-COUNT AMIKACIN IRA?

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

What is the FDA product code for COAT-A-COUNT AMIKACIN IRA?

The FDA product code for COAT-A-COUNT AMIKACIN IRA is KLQ.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

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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