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FDA 510(k)

FPR AMIKACIN CALIBRATOR KIT

K-Number: K894518 · 1989-09-28

ApplicantColony Laboratories, Inc.
Decision Date1989-09-28
Product CodeDLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FPR AMIKACIN CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894518. The device is classified under product code DLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPR AMIKACIN CALIBRATOR KIT?

FPR AMIKACIN CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894518.

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

FPR AMIKACIN CALIBRATOR KIT received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894518.

Who is the listed applicant for FPR AMIKACIN CALIBRATOR KIT?

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

What is the FDA product code for FPR AMIKACIN CALIBRATOR KIT?

The FDA product code for FPR AMIKACIN CALIBRATOR KIT is DLG.

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Other records listing Colony Laboratories, 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.

K894523FPR GENTAMICIN KITK894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894528FPR PHENYTOIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

View all 16 devices →

Related Devices (Code: DLG)

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.

K050988OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLSLin-Zhi International, Inc.K920419IL TEST DAT CAL/CONTROL SET D/EInstrumentation Laboratory COK894524FPR GENTAMICIN CALIBRATOR KITColony Laboratories, Inc.K894528FPR PHENYTOIN CALIBRATOR KITColony Laboratories, Inc.K882766EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95Em Diagnostic Systems, Inc.K833385N-ACETYLPROCAINAMIDE CALIBRATORE.I. Dupont DE Nemours & Co., 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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