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FDA 510(k)

COLORIMETRIC BUN

K-Number: K831414 · 1983-06-16

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1983-06-16
Product CodeCDL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC BUN 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 1983-06-16 under 510(k) number K831414. The device is classified under product code CDL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORIMETRIC BUN?

COLORIMETRIC BUN is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K831414.

When did COLORIMETRIC BUN receive FDA 510(k) clearance?

COLORIMETRIC BUN received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831414.

Who is the listed applicant for COLORIMETRIC BUN?

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 COLORIMETRIC BUN?

The FDA product code for COLORIMETRIC BUN is CDL.

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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 REAGENTK851513ULTRA-VIOLET BUN REAGENT KITK850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT

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Related Devices (Code: CDL)

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.

K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTReagents Applications, Inc.K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.

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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