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FDA 510(k)

ACCUSCAN MICROBEAD STANDARDS

K-Number: K902294 · 1990-07-03

ApplicantSigma Chemical Co.
Decision Date1990-07-03
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUSCAN MICROBEAD STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K902294. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSCAN MICROBEAD STANDARDS?

ACCUSCAN MICROBEAD STANDARDS is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Sigma Chemical Co.. The 510(k) number is K902294.

When did ACCUSCAN MICROBEAD STANDARDS receive FDA 510(k) clearance?

ACCUSCAN MICROBEAD STANDARDS received FDA 510(k) clearance on 1990-07-03, under 510(k) number K902294.

Who is the listed applicant for ACCUSCAN MICROBEAD STANDARDS?

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

What is the FDA product code for ACCUSCAN MICROBEAD STANDARDS?

The FDA product code for ACCUSCAN MICROBEAD STANDARDS is JIW.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933679SIGMA BUN REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: JIW)

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.

K973055WAKO CH50 LINEARITY SETWako Chemicals USA, Inc.K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, 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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