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FDA 510(k)

ULTRA-VIOLET GLUCOSE REAGENT

K-Number: K851514 · 1985-05-20

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1985-05-20
Product CodeCFA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA-VIOLET GLUCOSE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K851514. The device is classified under product code CFA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-VIOLET GLUCOSE REAGENT?

ULTRA-VIOLET GLUCOSE REAGENT is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K851514.

When did ULTRA-VIOLET GLUCOSE REAGENT receive FDA 510(k) clearance?

ULTRA-VIOLET GLUCOSE REAGENT received FDA 510(k) clearance on 1985-05-20, under 510(k) number K851514.

Who is the listed applicant for ULTRA-VIOLET GLUCOSE REAGENT?

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

What is the FDA product code for ULTRA-VIOLET GLUCOSE REAGENT?

The FDA product code for ULTRA-VIOLET GLUCOSE REAGENT is CFA.

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Other records listing Bio-Analytics 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK850639ENZYMATIC ALPHA-AMYLASE REAGENT KITK832771ERYTHROCYTE TEST

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Related Devices (Code: CFA)

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.

K863267MAGNESIUM PROCEDUREData Medical Associates, 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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