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)

STREP CULTURETTE

K-Number: K792201 · 1979-11-30

ApplicantMarion Health & Safety, Inc.
Decision Date1979-11-30
Product CodeJSN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP CULTURETTE is the device name listed in this FDA 510(k) record. The listed applicant is Marion Health & Safety, Inc.. It received FDA 510(k) clearance on 1979-11-30 under 510(k) number K792201. The device is classified under product code JSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREP CULTURETTE?

STREP CULTURETTE is a medical device that received FDA 510(k) clearance on 1979-11-30. The listed applicant is Marion Health & Safety, Inc.. The 510(k) number is K792201.

When did STREP CULTURETTE receive FDA 510(k) clearance?

STREP CULTURETTE received FDA 510(k) clearance on 1979-11-30, under 510(k) number K792201.

Who is the listed applicant for STREP CULTURETTE?

The FDA 510(k) record lists Marion Health & Safety, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STREP CULTURETTE?

The FDA product code for STREP CULTURETTE is JSN.

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 Marion Health & Safety, 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.

K800832VIRAL CULTURETTE HANK'S BAL. SALT SOL.

Related Devices (Code: JSN)

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.

K000718CHROMOSTREAKNovamed , Ltd.K962745ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)Prepared Media Laboratory, Inc.K961755CYTOQUANT CHLAMYDIA TRANSPORT MEDIUMProteins Intl., Inc.K961756CYTOQUANT VIRAL TRANSPORT MEDIUMProteins Intl., Inc.K896296INPOUCH-TV POUCHBiomed Diagnostics, Inc.K881579AMIES TRANSPORT MEDIUM W/O CHARCOALAcumedia 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.

↑