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)

MODIFICATION OF ABL MIC-10 PRECEPT SYS

K-Number: K843612 · 1985-02-19

ApplicantAustin Biological Laboratories
Decision Date1985-02-19
Product CodeLTD
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF ABL MIC-10 PRECEPT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1985-02-19 under 510(k) number K843612. The device is classified under product code LTD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF ABL MIC-10 PRECEPT SYS?

MODIFICATION OF ABL MIC-10 PRECEPT SYS is a medical device that received FDA 510(k) clearance on 1985-02-19. The listed applicant is Austin Biological Laboratories. The 510(k) number is K843612.

When did MODIFICATION OF ABL MIC-10 PRECEPT SYS receive FDA 510(k) clearance?

MODIFICATION OF ABL MIC-10 PRECEPT SYS received FDA 510(k) clearance on 1985-02-19, under 510(k) number K843612.

Who is the listed applicant for MODIFICATION OF ABL MIC-10 PRECEPT SYS?

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

What is the FDA product code for MODIFICATION OF ABL MIC-10 PRECEPT SYS?

The FDA product code for MODIFICATION OF ABL MIC-10 PRECEPT SYS is LTD.

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 Austin Biological Laboratories 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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

View all 45 devices →

Related Devices (Code: LTD)

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.

K843732API UNISCEPT MICAnalytical Products, 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.

↑