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)

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL

K-Number: K922482 · 1993-03-12

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-03-12
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-03-12 under 510(k) number K922482. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL?

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL is a medical device that received FDA 510(k) clearance on 1993-03-12. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922482.

When did MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL receive FDA 510(k) clearance?

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL received FDA 510(k) clearance on 1993-03-12, under 510(k) number K922482.

Who is the listed applicant for MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL?

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

What is the FDA product code for MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL?

The FDA product code for MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL is LRG.

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 Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

View all 72 devices →

Related Devices (Code: LRG)

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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, 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.

↑