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FDA 510(k)

FLOW CYTOMETRY FITC/PE COMPENSATION KIT

K-Number: K910255 · 1991-04-03

ApplicantSigma Diagnostics, Inc.
Decision Date1991-04-03
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW CYTOMETRY FITC/PE COMPENSATION KIT 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 1991-04-03 under 510(k) number K910255. 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 FLOW CYTOMETRY FITC/PE COMPENSATION KIT?

FLOW CYTOMETRY FITC/PE COMPENSATION KIT is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K910255.

When did FLOW CYTOMETRY FITC/PE COMPENSATION KIT receive FDA 510(k) clearance?

FLOW CYTOMETRY FITC/PE COMPENSATION KIT received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910255.

Who is the listed applicant for FLOW CYTOMETRY FITC/PE COMPENSATION KIT?

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 FLOW CYTOMETRY FITC/PE COMPENSATION KIT?

The FDA product code for FLOW CYTOMETRY FITC/PE COMPENSATION KIT is JIW.

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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: 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.K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.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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