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FDA 510(k)

FPR PHENOBARBITAL KIT

K-Number: K894525 · 1989-08-28

ApplicantColony Laboratories, Inc.
Decision Date1989-08-28
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR PHENOBARBITAL 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 1989-08-28 under 510(k) number K894525. The device is classified under product code LGQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPR PHENOBARBITAL KIT?

FPR PHENOBARBITAL KIT is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894525.

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

FPR PHENOBARBITAL KIT received FDA 510(k) clearance on 1989-08-28, under 510(k) number K894525.

Who is the listed applicant for FPR PHENOBARBITAL 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 PHENOBARBITAL KIT?

The FDA product code for FPR PHENOBARBITAL KIT is LGQ.

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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.

K894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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Related Devices (Code: LGQ)

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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.K940596AXSYM PHENOBARBITALAbbott LaboratoriesK936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.K872397COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.Roche 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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