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)

AMES TDA TM PRIMIDONE TEST

K-Number: K811007 · 1981-04-29

ApplicantMiles Laboratories, Inc.
Decision Date1981-04-29
Product CodeLFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA TM PRIMIDONE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K811007. The device is classified under product code LFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA TM PRIMIDONE TEST?

AMES TDA TM PRIMIDONE TEST is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K811007.

When did AMES TDA TM PRIMIDONE TEST receive FDA 510(k) clearance?

AMES TDA TM PRIMIDONE TEST received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811007.

Who is the listed applicant for AMES TDA TM PRIMIDONE TEST?

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

What is the FDA product code for AMES TDA TM PRIMIDONE TEST?

The FDA product code for AMES TDA TM PRIMIDONE TEST is LFT.

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 Miles 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

View all 158 devices →

Related Devices (Code: LFT)

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.

K950028PRIMIDONE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K904683STRATUS PRIMIDONE FLUOROMETRIC ENZYMEBaxter Healthcare CorpK895567PRIMIDONE (FPIA) KITTudor Laboratories, Inc.K852318COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSRoche Diagnostic Systems, Inc.K842196STRATUS PRIMIDONE FLOROMETRIC ENZYAmerican DadeK823741ADVANCE EMIT-AED PRIMEDONE ASSAYSyva Co.

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.

↑