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)

NEG COMBO BREAKPOINT PANEL POS COMBO

K-Number: K854278 · 1986-03-04

ApplicantAmerican Micro Scan
Decision Date1986-03-04
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEG COMBO BREAKPOINT PANEL POS COMBO is the device name listed in this FDA 510(k) record. The listed applicant is American Micro Scan. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K854278. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEG COMBO BREAKPOINT PANEL POS COMBO?

NEG COMBO BREAKPOINT PANEL POS COMBO is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is American Micro Scan. The 510(k) number is K854278.

When did NEG COMBO BREAKPOINT PANEL POS COMBO receive FDA 510(k) clearance?

NEG COMBO BREAKPOINT PANEL POS COMBO received FDA 510(k) clearance on 1986-03-04, under 510(k) number K854278.

Who is the listed applicant for NEG COMBO BREAKPOINT PANEL POS COMBO?

The FDA 510(k) record lists American Micro Scan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEG COMBO BREAKPOINT PANEL POS COMBO?

The FDA product code for NEG COMBO BREAKPOINT PANEL POS COMBO is JWX.

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 American Micro Scan 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.

K864662CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSK870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEK863776MICRODILUTION MIC PANELSK864674MICRODILUTION IDENTIFICATION PANELSK864389CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTK863038GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

View all 24 devices →

Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, 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.

↑