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FDA 510(k)

CALIBRATOR 282

K-Number: K831872 · 1983-07-18

ApplicantBionostics, Inc.
Decision Date1983-07-18
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALIBRATOR 282 is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831872. 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 CALIBRATOR 282?

CALIBRATOR 282 is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Bionostics, Inc.. The 510(k) number is K831872.

When did CALIBRATOR 282 receive FDA 510(k) clearance?

CALIBRATOR 282 received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831872.

Who is the listed applicant for CALIBRATOR 282?

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

What is the FDA product code for CALIBRATOR 282?

The FDA product code for CALIBRATOR 282 is KRZ.

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Other records listing Bionostics, Inc. as applicant

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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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