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FDA 510(k)

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)

K-Number: K854733 · 1986-03-06

ApplicantDms Products, Inc.
Decision Date1986-03-06
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Dms Products, Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K854733. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)?

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Dms Products, Inc.. The 510(k) number is K854733.

When did API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) receive FDA 510(k) clearance?

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) received FDA 510(k) clearance on 1986-03-06, under 510(k) number K854733.

Who is the listed applicant for API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)?

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

What is the FDA product code for API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)?

The FDA product code for API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) is JSS.

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 Dms Products, 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.

K891004RAPIDEC STAPHK894805RAPIDEC URK890626RAPIDEC COLIK890625JAMES REAGENTK854732API 50 CHB (CULTURE MEDIA)

Related Devices (Code: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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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