Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERAPEUTIC DRUG STANDARD

K-Number: K880705 · 1988-05-31

ApplicantVerichem Laboratories, Inc.
Decision Date1988-05-31
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC DRUG STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K880705. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC DRUG STANDARD?

THERAPEUTIC DRUG STANDARD is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K880705.

When did THERAPEUTIC DRUG STANDARD receive FDA 510(k) clearance?

THERAPEUTIC DRUG STANDARD received FDA 510(k) clearance on 1988-05-31, under 510(k) number K880705.

Who is the listed applicant for THERAPEUTIC DRUG STANDARD?

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

What is the FDA product code for THERAPEUTIC DRUG STANDARD?

The FDA product code for THERAPEUTIC DRUG STANDARD is DKB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Verichem 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.

K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESK974290MICROPROTEIN STANDARD KITK973345MATRIX PLUS MULTI-CALIBRATOR KITK972333AMMONIA/IRON STANDARD KITK924904HDL-CHOLESTEROL STANDARD, MODIFICATIONK912513ELECTROLYTE CONTROL

View all 14 devices →

Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)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.

↑