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FDA 510(k)

ENZYMATIC BUN REAGENT KIT

K-Number: K760414 · 1976-11-05

ApplicantBeckman Instruments, Inc.
Decision Date1976-11-05
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC BUN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1976-11-05 under 510(k) number K760414. 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 ENZYMATIC BUN REAGENT KIT?

ENZYMATIC BUN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1976-11-05. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K760414.

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

ENZYMATIC BUN REAGENT KIT received FDA 510(k) clearance on 1976-11-05, under 510(k) number K760414.

Who is the listed applicant for ENZYMATIC BUN REAGENT KIT?

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

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

The FDA product code for ENZYMATIC BUN REAGENT KIT is CDQ.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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