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FDA 510(k)

VALPROIC ACID (FPIA) CALIBRATOR KIT

K-Number: K895570 · 1989-09-28

ApplicantTudor Laboratories, Inc.
Decision Date1989-09-28
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VALPROIC ACID (FPIA) CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tudor Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K895570. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALPROIC ACID (FPIA) CALIBRATOR KIT?

VALPROIC ACID (FPIA) CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Tudor Laboratories, Inc.. The 510(k) number is K895570.

When did VALPROIC ACID (FPIA) CALIBRATOR KIT receive FDA 510(k) clearance?

VALPROIC ACID (FPIA) CALIBRATOR KIT received FDA 510(k) clearance on 1989-09-28, under 510(k) number K895570.

Who is the listed applicant for VALPROIC ACID (FPIA) CALIBRATOR KIT?

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

What is the FDA product code for VALPROIC ACID (FPIA) CALIBRATOR KIT?

The FDA product code for VALPROIC ACID (FPIA) CALIBRATOR KIT is DLJ.

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Other records listing Tudor Laboratories, 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.

K921904THYROXINE (FPIA) KITK921903THYROXINE CALIBRATOR KITK913240DIGITOXIN (FPIA) KITK895572N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KITK895571N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITK895567PRIMIDONE (FPIA) KIT

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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