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FDA 510(k)

MSI-CAL 16

K-Number: K883850 · 1988-11-22

ApplicantMedical Specialties, Inc.
Decision Date1988-11-22
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MSI-CAL 16 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1988-11-22 under 510(k) number K883850. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSI-CAL 16?

MSI-CAL 16 is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K883850.

When did MSI-CAL 16 receive FDA 510(k) clearance?

MSI-CAL 16 received FDA 510(k) clearance on 1988-11-22, under 510(k) number K883850.

Who is the listed applicant for MSI-CAL 16?

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

What is the FDA product code for MSI-CAL 16?

The FDA product code for MSI-CAL 16 is KRZ.

Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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Related Devices (Code: KRZ)

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.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents 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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