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FDA 510(k)

IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS

K-Number: K865102 · 1987-01-13

ApplicantSclavo, Inc.
Decision Date1987-01-13
Product CodeLES
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE COATED TUBE PHENYTOIN 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 1987-01-13 under 510(k) number K865102. The device is classified under product code LES. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS?

IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Sclavo, Inc.. The 510(k) number is K865102.

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

IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS received FDA 510(k) clearance on 1987-01-13, under 510(k) number K865102.

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

The FDA product code for IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS is LES.

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Other records listing Sclavo, Inc. as applicant

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Related Devices (Code: LES)

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.

K844990SYVA ADVANCE EMIT PHENYTOIN ASSAYSyva Co.K831154STRATUS PHENYTOIN FLUOROMETRIC ENZYMEAmerican DadeK820187SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENYSyva Co.K813538PHENYTOIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.K811025AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.K801736AMES TDA TM PHENYTOIN 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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