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FDA 510(k)

PGUA-INDOL MICROTUBE

K-Number: K812467 · 1981-09-14

ApplicantCarr Microbiologicals
Decision Date1981-09-14
Product CodeJSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PGUA-INDOL MICROTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Carr Microbiologicals. It received FDA 510(k) clearance on 1981-09-14 under 510(k) number K812467. The device is classified under product code JSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PGUA-INDOL MICROTUBE?

PGUA-INDOL MICROTUBE is a medical device that received FDA 510(k) clearance on 1981-09-14. The listed applicant is Carr Microbiologicals. The 510(k) number is K812467.

When did PGUA-INDOL MICROTUBE receive FDA 510(k) clearance?

PGUA-INDOL MICROTUBE received FDA 510(k) clearance on 1981-09-14, under 510(k) number K812467.

Who is the listed applicant for PGUA-INDOL MICROTUBE?

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

What is the FDA product code for PGUA-INDOL MICROTUBE?

The FDA product code for PGUA-INDOL MICROTUBE is JSE.

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 Carr Microbiologicals 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.

K812469RAPID DECARBOXYLASE/DIHYDROLASE MICROTUBK812468PYRR MICROTUBEK812465PHOS MICROTUBESK812470HIPP MICROTUBEK812466ONPX-INDOL MEDIUM MICROTUBES

Related Devices (Code: JSE)

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.

K962265MLX MICROTITER PLATE LUMINOMETERDynatech Laboratories, Inc.K883995X-ACT UREA/TDAPro-Lab, Inc.K883996X-ACT LDC/INDPro-Lab, Inc.K880133MIL MEDIUMHardy MediaK880116MRVP BROTHHardy MediaK874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARLakewood Biochemical Co., 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.

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