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FDA 510(k)

IMMPULSE PHENOBARBITAL ASSAY REAGENTS

K-Number: K862528 · 1986-07-16

ApplicantSclavo, Inc.
Decision Date1986-07-16
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE PHENOBARBITAL ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862528. 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 IMMPULSE PHENOBARBITAL ASSAY REAGENTS?

IMMPULSE PHENOBARBITAL ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Sclavo, Inc.. The 510(k) number is K862528.

When did IMMPULSE PHENOBARBITAL ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE PHENOBARBITAL ASSAY REAGENTS received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862528.

Who is the listed applicant for IMMPULSE PHENOBARBITAL ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE PHENOBARBITAL ASSAY REAGENTS?

The FDA product code for IMMPULSE PHENOBARBITAL ASSAY REAGENTS is LGQ.

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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.K894525FPR PHENOBARBITAL KITColony Laboratories, 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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