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FDA 510(k)

IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS

K-Number: K865000 · 1987-02-06

ApplicantSclavo, Inc.
Decision Date1987-02-06
Product CodeLET
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE COATED TUBE 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 1987-02-06 under 510(k) number K865000. The device is classified under product code LET. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS?

IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Sclavo, Inc.. The 510(k) number is K865000.

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

IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS received FDA 510(k) clearance on 1987-02-06, under 510(k) number K865000.

Who is the listed applicant for IMMPULSE COATED TUBE 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 COATED TUBE PHENOBARBITAL ASSAY REAGENTS?

The FDA product code for IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS is LET.

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Related Devices (Code: LET)

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.

K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.K842592AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.K830701STRATUS PHENOBARBITAL FLUOROMETRIC ENZAmerican DadeK821408PHENOBARBITAL FLUORESCENT IMMUNOAmerican Diagnostic Corp.K820188PHENOBARBITAL ASSAYSyva Co.K810994AMES TDA TM PHENOBARBITAL TESTMiles 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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