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FDA 510(k)

SERUM, CONTROL, DRUGS, ANTIARRYTHMIC

K-Number: K780960 · 1978-12-07

ApplicantVitek Systems, Inc.
Decision Date1978-12-07
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERUM, CONTROL, DRUGS, ANTIARRYTHMIC is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K780960. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM, CONTROL, DRUGS, ANTIARRYTHMIC?

SERUM, CONTROL, DRUGS, ANTIARRYTHMIC is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K780960.

When did SERUM, CONTROL, DRUGS, ANTIARRYTHMIC receive FDA 510(k) clearance?

SERUM, CONTROL, DRUGS, ANTIARRYTHMIC received FDA 510(k) clearance on 1978-12-07, under 510(k) number K780960.

Who is the listed applicant for SERUM, CONTROL, DRUGS, ANTIARRYTHMIC?

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

What is the FDA product code for SERUM, CONTROL, DRUGS, ANTIARRYTHMIC?

The FDA product code for SERUM, CONTROL, DRUGS, ANTIARRYTHMIC is DIF.

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Related Devices (Code: DIF)

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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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