FDA 510(k)

DNASE TEST AGAR

K-Number: K791671 · 1979-10-01

ApplicantIsle Media and Sterile Products, Inc.

Decision Date1979-10-01

Product CodeJSH

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

DNASE TEST AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Isle Media and Sterile Products, Inc.. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791671. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DNASE TEST AGAR?

DNASE TEST AGAR is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K791671.

When did DNASE TEST AGAR receive FDA 510(k) clearance?

DNASE TEST AGAR received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791671.

Who is the listed applicant for DNASE TEST AGAR?

The FDA 510(k) record lists Isle Media and Sterile Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNASE TEST AGAR?

The FDA product code for DNASE TEST AGAR is JSH.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Isle Media and Sterile Products, Inc. as applicant

K831671MODIFIED SOYBEAN CASEIN DIGEST BROTH K821218CAMPY-S AGAR K820863MEDIA FOR IN-VITRO DIAGNOSTIC USE K812796ANAEROBIC CNA BLOOD AGAR K812795ANAEROBIC BLOOD AGAR K812798MOTILITY GI MEDIUM

View all 93 devices →

Related Devices (Code: JSH)

K881551PHENOL RED BROTH BASEAcumedia Manufacturers, Inc.K881553RUSSELL DOUBLE SUGAR AGARAcumedia Manufacturers, Inc.K881486DNASE TEST AGARAcumedia Manufacturers, Inc.K881540FLO AGARAcumedia Manufacturers, Inc.K881559UREA AGAR BASEAcumedia Manufacturers, Inc.K881560UREA BROTHAcumedia 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.