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)

MYCOSEL AGAR W/CHLORAMPHENICOL &

K-Number: K841135 · 1984-03-26

ApplicantAnaerobe Systems
Decision Date1984-03-26
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOSEL AGAR W/CHLORAMPHENICOL & is the device name listed in this FDA 510(k) record. The listed applicant is Anaerobe Systems. It received FDA 510(k) clearance on 1984-03-26 under 510(k) number K841135. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOSEL AGAR W/CHLORAMPHENICOL &?

MYCOSEL AGAR W/CHLORAMPHENICOL & is a medical device that received FDA 510(k) clearance on 1984-03-26. The listed applicant is Anaerobe Systems. The 510(k) number is K841135.

When did MYCOSEL AGAR W/CHLORAMPHENICOL & receive FDA 510(k) clearance?

MYCOSEL AGAR W/CHLORAMPHENICOL & received FDA 510(k) clearance on 1984-03-26, under 510(k) number K841135.

Who is the listed applicant for MYCOSEL AGAR W/CHLORAMPHENICOL &?

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

What is the FDA product code for MYCOSEL AGAR W/CHLORAMPHENICOL &?

The FDA product code for MYCOSEL AGAR W/CHLORAMPHENICOL & is JSJ.

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 Anaerobe Systems 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.

K844381COLISTIN 10 MCG. DIFFERENTIAL DISKK844382VANCOMYCIN 5MCG DIFFERENTIAL DISKK844383KANAMYCIN 1000 MCG DIFFERENTIAL DISKK844380BILE DIFFERENTIAL DISKK841303CAMPYLOBACTER THIOGLYCOLLATE MEDK841142LEVINE EOSIN METHYLENE BLUE AGAR

View all 52 devices →

Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia 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.

↑