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)

DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS

K-Number: K863525 · 1986-09-19

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1986-09-19
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1986-09-19 under 510(k) number K863525. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS?

DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K863525.

When did DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS receive FDA 510(k) clearance?

DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS received FDA 510(k) clearance on 1986-09-19, under 510(k) number K863525.

Who is the listed applicant for DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS?

The FDA product code for DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS is JSI.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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.

↑