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)

MODIFIED FOX EXTRA GRAM POSITIVE

K-Number: K945997 · 1995-02-16

ApplicantMicro-Media Systems, Inc.
Decision Date1995-02-16
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED FOX EXTRA GRAM POSITIVE is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Media Systems, Inc.. It received FDA 510(k) clearance on 1995-02-16 under 510(k) number K945997. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED FOX EXTRA GRAM POSITIVE?

MODIFIED FOX EXTRA GRAM POSITIVE is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is Micro-Media Systems, Inc.. The 510(k) number is K945997.

When did MODIFIED FOX EXTRA GRAM POSITIVE receive FDA 510(k) clearance?

MODIFIED FOX EXTRA GRAM POSITIVE received FDA 510(k) clearance on 1995-02-16, under 510(k) number K945997.

Who is the listed applicant for MODIFIED FOX EXTRA GRAM POSITIVE?

The FDA 510(k) record lists Micro-Media Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED FOX EXTRA GRAM POSITIVE?

The FDA product code for MODIFIED FOX EXTRA GRAM POSITIVE is JWY.

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 Micro-Media Systems, 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.

K953422FOX FASTIDIOUS TEST PANELSK823738GRAM NEGATIVE BACTERIAL IDENTIF- PANELSK801547TEST PANEL FOR PRESUMP. ID/BACT. ORGK791991STREP-SPECK770745PANEL, GNF, MICRO-IDK770746PANEL, IDENTIFICATION, STREP, MICRO-ID

View all 7 devices →

Related Devices (Code: JWY)

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.

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

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.

↑