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FDA 510(k)

ISOCONTROL SERUM LD-

K-Number: K850211 · 1985-02-07

ApplicantSclavo, Inc.
Decision Date1985-02-07
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOCONTROL SERUM LD- is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K850211. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOCONTROL SERUM LD-?

ISOCONTROL SERUM LD- is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Sclavo, Inc.. The 510(k) number is K850211.

When did ISOCONTROL SERUM LD- receive FDA 510(k) clearance?

ISOCONTROL SERUM LD- received FDA 510(k) clearance on 1985-02-07, under 510(k) number K850211.

Who is the listed applicant for ISOCONTROL SERUM LD-?

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

What is the FDA product code for ISOCONTROL SERUM LD-?

The FDA product code for ISOCONTROL SERUM LD- is JJT.

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Related Devices (Code: JJT)

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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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