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FDA 510(k)

ANTICONVULSANTS III CALIBRATOR KIT

K-Number: K780733 · 1978-06-22

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

Device Summary

ANTICONVULSANTS III 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 K780733. The device is classified under product code DKH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTICONVULSANTS III CALIBRATOR KIT?

ANTICONVULSANTS III 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 K780733.

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

ANTICONVULSANTS III CALIBRATOR KIT received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780733.

Who is the listed applicant for ANTICONVULSANTS III 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 III CALIBRATOR KIT?

The FDA product code for ANTICONVULSANTS III CALIBRATOR KIT is DKH.

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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

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Related Devices (Code: DKH)

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.

K801276DUPONT PREP APPLI. FOR PHENOBARBITAL,E.I. Dupont DE Nemours & Co., Inc.

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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