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 THEOPHYL-LINE TEST

K-Number: K800646 · 1980-04-10

ApplicantMiles Laboratories, Inc.
Decision Date1980-04-10
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA THEOPHYL-LINE 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 1980-04-10 under 510(k) number K800646. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA THEOPHYL-LINE TEST?

AMES TDA THEOPHYL-LINE TEST is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800646.

When did AMES TDA THEOPHYL-LINE TEST receive FDA 510(k) clearance?

AMES TDA THEOPHYL-LINE TEST received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800646.

Who is the listed applicant for AMES TDA THEOPHYL-LINE 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 THEOPHYL-LINE TEST?

The FDA product code for AMES TDA THEOPHYL-LINE TEST is KLS.

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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., 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.

↑