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FDA 510(k)

REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT

K-Number: K920397 · 1992-08-04

ApplicantMedical Analysis Systems, Inc.
Decision Date1992-08-04
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1992-08-04 under 510(k) number K920397. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT?

REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT is a medical device that received FDA 510(k) clearance on 1992-08-04. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K920397.

When did REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT receive FDA 510(k) clearance?

REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT received FDA 510(k) clearance on 1992-08-04, under 510(k) number K920397.

Who is the listed applicant for REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT?

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

What is the FDA product code for REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT?

The FDA product code for REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT is LCP.

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Related Devices (Code: LCP)

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.

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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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