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FDA 510(k)

BLOOD UREA NITROGEN (BUN) PROCEDURE

K-Number: K861666 · 1986-07-01

ApplicantData Medical Associates, Inc.
Decision Date1986-07-01
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN (BUN) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K861666. 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 BLOOD UREA NITROGEN (BUN) PROCEDURE?

BLOOD UREA NITROGEN (BUN) PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K861666.

When did BLOOD UREA NITROGEN (BUN) PROCEDURE receive FDA 510(k) clearance?

BLOOD UREA NITROGEN (BUN) PROCEDURE received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861666.

Who is the listed applicant for BLOOD UREA NITROGEN (BUN) PROCEDURE?

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

What is the FDA product code for BLOOD UREA NITROGEN (BUN) PROCEDURE?

The FDA product code for BLOOD UREA NITROGEN (BUN) PROCEDURE is CDQ.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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