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FDA 510(k)

LEVEL II LIPID CONTROL

K-Number: K821560 · 1982-07-13

ApplicantIrvine Scientific
Decision Date1982-07-13
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEVEL II LIPID CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821560. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVEL II LIPID CONTROL?

LEVEL II LIPID CONTROL is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Irvine Scientific. The 510(k) number is K821560.

When did LEVEL II LIPID CONTROL receive FDA 510(k) clearance?

LEVEL II LIPID CONTROL received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821560.

Who is the listed applicant for LEVEL II LIPID CONTROL?

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

What is the FDA product code for LEVEL II LIPID CONTROL?

The FDA product code for LEVEL II LIPID CONTROL is JJY.

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Related Devices (Code: JJY)

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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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