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FDA 510(k)

IGE/THE OPHYLLINE CONTROL SERUM I,II,III

K-Number: K822133 · 1982-08-03

ApplicantKallestad Laboratories, Inc.
Decision Date1982-08-03
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IGE/THE OPHYLLINE CONTROL SERUM I,II,III is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1982-08-03 under 510(k) number K822133. 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 IGE/THE OPHYLLINE CONTROL SERUM I,II,III?

IGE/THE OPHYLLINE CONTROL SERUM I,II,III is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K822133.

When did IGE/THE OPHYLLINE CONTROL SERUM I,II,III receive FDA 510(k) clearance?

IGE/THE OPHYLLINE CONTROL SERUM I,II,III received FDA 510(k) clearance on 1982-08-03, under 510(k) number K822133.

Who is the listed applicant for IGE/THE OPHYLLINE CONTROL SERUM I,II,III?

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

What is the FDA product code for IGE/THE OPHYLLINE CONTROL SERUM I,II,III?

The FDA product code for IGE/THE OPHYLLINE CONTROL SERUM I,II,III 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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