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FDA 510(k)

BILE ACIDS CALIBRATOR

K-Number: K872451 · 1987-08-21

ApplicantSigma Diagnostics, Inc.
Decision Date1987-08-21
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILE ACIDS CALIBRATOR 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 1987-08-21 under 510(k) number K872451. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILE ACIDS CALIBRATOR?

BILE ACIDS CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-08-21. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K872451.

When did BILE ACIDS CALIBRATOR receive FDA 510(k) clearance?

BILE ACIDS CALIBRATOR received FDA 510(k) clearance on 1987-08-21, under 510(k) number K872451.

Who is the listed applicant for BILE ACIDS CALIBRATOR?

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 BILE ACIDS CALIBRATOR?

The FDA product code for BILE ACIDS CALIBRATOR is JIT.

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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: JIT)

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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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