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FDA 510(k)

COLORIMETRIC BUN REAGENT KIT

K-Number: K871651 · 1987-05-12

ApplicantBiochemical Trade, Inc.
Decision Date1987-05-12
Product CodeCDL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC BUN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K871651. 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 REAGENT KIT?

COLORIMETRIC BUN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K871651.

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

COLORIMETRIC BUN REAGENT KIT received FDA 510(k) clearance on 1987-05-12, under 510(k) number K871651.

Who is the listed applicant for COLORIMETRIC BUN REAGENT KIT?

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

What is the FDA product code for COLORIMETRIC BUN REAGENT KIT?

The FDA product code for COLORIMETRIC BUN REAGENT KIT is CDL.

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Other records listing Biochemical Trade, Inc. as applicant

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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 LaboratoryK864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETSterling 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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