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FDA 510(k)

SIGMA'S CALCIUM PROCEDURE NO. 587

K-Number: K871152 · 1987-06-12

ApplicantSigma Diagnostics, Inc.
Decision Date1987-06-12
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA'S CALCIUM PROCEDURE NO. 587 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 1987-06-12 under 510(k) number K871152. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA'S CALCIUM PROCEDURE NO. 587?

SIGMA'S CALCIUM PROCEDURE NO. 587 is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K871152.

When did SIGMA'S CALCIUM PROCEDURE NO. 587 receive FDA 510(k) clearance?

SIGMA'S CALCIUM PROCEDURE NO. 587 received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871152.

Who is the listed applicant for SIGMA'S CALCIUM PROCEDURE NO. 587?

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'S CALCIUM PROCEDURE NO. 587?

The FDA product code for SIGMA'S CALCIUM PROCEDURE NO. 587 is CIC.

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Other records listing Sigma Diagnostics, Inc. as applicant

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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: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen 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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