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FDA 510(k)

OLYMPUS SERUM PROTEIN MULTICALIBRATOR,

K-Number: K981854 · 1998-08-18

ApplicantOlympus Diagnostica GmbH
Decision Date1998-08-18
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS SERUM PROTEIN MULTICALIBRATOR, is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Diagnostica GmbH. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K981854. 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 OLYMPUS SERUM PROTEIN MULTICALIBRATOR,?

OLYMPUS SERUM PROTEIN MULTICALIBRATOR, is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Olympus Diagnostica GmbH. The 510(k) number is K981854.

When did OLYMPUS SERUM PROTEIN MULTICALIBRATOR, receive FDA 510(k) clearance?

OLYMPUS SERUM PROTEIN MULTICALIBRATOR, received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981854.

Who is the listed applicant for OLYMPUS SERUM PROTEIN MULTICALIBRATOR,?

The FDA 510(k) record lists Olympus Diagnostica GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS SERUM PROTEIN MULTICALIBRATOR,?

The FDA product code for OLYMPUS SERUM PROTEIN MULTICALIBRATOR, is JIT.

Related Clinical Trials

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.

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Other records listing Olympus Diagnostica GmbH 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.

K994189OLYMPUS CREATINE KINASE REAGENT OSR6179/6279K984145OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENTK982035OLYMPUS CALCIUM ARSENAZO III REAGENT

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio 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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