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FDA 510(k)

LEVEL II CONTROL SERUM

K-Number: K821558 · 1982-07-02

ApplicantIrvine Scientific
Decision Date1982-07-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEVEL II CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821558. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVEL II CONTROL SERUM?

LEVEL II CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Irvine Scientific. The 510(k) number is K821558.

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

LEVEL II CONTROL SERUM received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821558.

Who is the listed applicant for LEVEL II CONTROL SERUM?

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 CONTROL SERUM?

The FDA product code for LEVEL II CONTROL SERUM is JJX.

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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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