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FDA 510(k)

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

K-Number: K992800 · 1999-09-28

ApplicantSigma Diagnostics, Inc.
Decision Date1999-09-28
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-09-28 under 510(k) number K992800. 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 SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P?

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P is a medical device that received FDA 510(k) clearance on 1999-09-28. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K992800.

When did SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P received FDA 510(k) clearance on 1999-09-28, under 510(k) number K992800.

Who is the listed applicant for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P?

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

What is the FDA product code for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P?

The FDA product code for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P is CDQ.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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