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FDA 510(k)

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

K-Number: K855014 · 1986-03-14

ApplicantKallestad Laboratories, Inc.
Decision Date1986-03-14
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K855014. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A?

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K855014.

When did QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A receive FDA 510(k) clearance?

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A received FDA 510(k) clearance on 1986-03-14, under 510(k) number K855014.

Who is the listed applicant for QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A?

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

What is the FDA product code for QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A?

The FDA product code for QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A is JIX.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare 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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