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FDA 510(k)

ANTICONVULSANTS II CALIBRATOR KIT

K-Number: K780734 · 1978-06-22

ApplicantVitek Systems, Inc.
Decision Date1978-06-22
Product CodeDIY
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ANTICONVULSANTS II CALIBRATOR KIT 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 1978-06-22 under 510(k) number K780734. The device is classified under product code DIY. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTICONVULSANTS II CALIBRATOR KIT?

ANTICONVULSANTS II CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K780734.

When did ANTICONVULSANTS II CALIBRATOR KIT receive FDA 510(k) clearance?

ANTICONVULSANTS II CALIBRATOR KIT received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780734.

Who is the listed applicant for ANTICONVULSANTS II CALIBRATOR KIT?

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 ANTICONVULSANTS II CALIBRATOR KIT?

The FDA product code for ANTICONVULSANTS II CALIBRATOR KIT is DIY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Vitek Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

View all 39 devices →

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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