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FDA 510(k)

UREA NITROGEN-BUN-REAGENTS B6370-11A

K-Number: K831626 · 1983-07-07

ApplicantAmerican Scientific Products
Decision Date1983-07-07
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN-BUN-REAGENTS B6370-11A is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831626. 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 UREA NITROGEN-BUN-REAGENTS B6370-11A?

UREA NITROGEN-BUN-REAGENTS B6370-11A is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is American Scientific Products. The 510(k) number is K831626.

When did UREA NITROGEN-BUN-REAGENTS B6370-11A receive FDA 510(k) clearance?

UREA NITROGEN-BUN-REAGENTS B6370-11A received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831626.

Who is the listed applicant for UREA NITROGEN-BUN-REAGENTS B6370-11A?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA NITROGEN-BUN-REAGENTS B6370-11A?

The FDA product code for UREA NITROGEN-BUN-REAGENTS B6370-11A is CDQ.

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Other records listing American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831628CREATININE REAGENTS B6370-13K831627CREATININE REAGENTS B6360-10

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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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