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FDA 510(k)

ULTRA-VIOLET BUN REAGENT KIT

K-Number: K851513 · 1985-05-20

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

Device Summary

ULTRA-VIOLET BUN REAGENT KIT 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 K851513. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-VIOLET BUN REAGENT KIT?

ULTRA-VIOLET BUN REAGENT KIT 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 K851513.

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

ULTRA-VIOLET BUN REAGENT KIT received FDA 510(k) clearance on 1985-05-20, under 510(k) number K851513.

Who is the listed applicant for ULTRA-VIOLET BUN REAGENT KIT?

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 BUN REAGENT KIT?

The FDA product code for ULTRA-VIOLET BUN REAGENT KIT is CDQ.

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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 KITK851514ULTRA-VIOLET GLUCOSE REAGENTK850639ENZYMATIC ALPHA-AMYLASE REAGENT KITK832771ERYTHROCYTE TEST

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Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, 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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