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)

AMS YEAST BIOCHEMICAL CARD

K-Number: K792231 · 1979-12-19

ApplicantVitek Systems, Inc.
Decision Date1979-12-19
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMS YEAST BIOCHEMICAL CARD is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K792231. The device is classified under product code JXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS YEAST BIOCHEMICAL CARD?

AMS YEAST BIOCHEMICAL CARD is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K792231.

When did AMS YEAST BIOCHEMICAL CARD receive FDA 510(k) clearance?

AMS YEAST BIOCHEMICAL CARD received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792231.

Who is the listed applicant for AMS YEAST BIOCHEMICAL CARD?

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

What is the FDA product code for AMS YEAST BIOCHEMICAL CARD?

The FDA product code for AMS YEAST BIOCHEMICAL CARD is JXB.

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 Vitek 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.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

View all 39 devices →

Related Devices (Code: JXB)

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.

K080719YEAST TRAFFIC LIGHT PNA FISHAdvandx, Inc.K062461C. ALBICANS PNA FISHAdvandx, Inc.K993554YEASTESTDiagnostic Markers, Inc.K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.K935124BACTICARD CANDIDARemel Co.K900112MICRORING YTMedical Wire & Equipment Co.

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.

↑