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FDA 510(k)

THEOPHYLLINE CONTROL SERUM

K-Number: K780961 · 1978-12-07

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

Device Summary

THEOPHYLLINE CONTROL SERUM 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 K780961. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE CONTROL SERUM?

THEOPHYLLINE CONTROL SERUM 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 K780961.

When did THEOPHYLLINE CONTROL SERUM receive FDA 510(k) clearance?

THEOPHYLLINE CONTROL SERUM received FDA 510(k) clearance on 1978-12-07, under 510(k) number K780961.

Who is the listed applicant for THEOPHYLLINE CONTROL SERUM?

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 THEOPHYLLINE CONTROL SERUM?

The FDA product code for THEOPHYLLINE CONTROL SERUM is LAS.

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Other records listing Vitek Systems, Inc. as applicant

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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: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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