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FDA 510(k)

TRIGLYCERIDE CALIBRATOR

K-Number: K822852 · 1982-10-27

ApplicantHarleco Diagnostics
Decision Date1982-10-27
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822852. 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 TRIGLYCERIDE CALIBRATOR?

TRIGLYCERIDE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Harleco Diagnostics. The 510(k) number is K822852.

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

TRIGLYCERIDE CALIBRATOR received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822852.

Who is the listed applicant for TRIGLYCERIDE CALIBRATOR?

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

What is the FDA product code for TRIGLYCERIDE CALIBRATOR?

The FDA product code for TRIGLYCERIDE CALIBRATOR is 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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