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FDA 510(k)

UREA NITROGEN(BUN), COLORIMETRIC METHOD

K-Number: K864742 · 1987-01-13

ApplicantTech-Co, Inc.
Decision Date1987-01-13
Product CodeCDL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN(BUN), COLORIMETRIC METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864742. 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 UREA NITROGEN(BUN), COLORIMETRIC METHOD?

UREA NITROGEN(BUN), COLORIMETRIC METHOD is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Tech-Co, Inc.. The 510(k) number is K864742.

When did UREA NITROGEN(BUN), COLORIMETRIC METHOD receive FDA 510(k) clearance?

UREA NITROGEN(BUN), COLORIMETRIC METHOD received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864742.

Who is the listed applicant for UREA NITROGEN(BUN), COLORIMETRIC METHOD?

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

What is the FDA product code for UREA NITROGEN(BUN), COLORIMETRIC METHOD?

The FDA product code for UREA NITROGEN(BUN), COLORIMETRIC METHOD is CDL.

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Other records listing Tech-Co, 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 LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, 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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