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FDA 510(k)

BITEK(TM) BLOOD CULTURE SYSTEM

K-Number: K875273 · 1988-01-22

ApplicantDefinitive Diagnostics, Inc.
Decision Date1988-01-22
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BITEK(TM) BLOOD CULTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Definitive Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K875273. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITEK(TM) BLOOD CULTURE SYSTEM?

BITEK(TM) BLOOD CULTURE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Definitive Diagnostics, Inc.. The 510(k) number is K875273.

When did BITEK(TM) BLOOD CULTURE SYSTEM receive FDA 510(k) clearance?

BITEK(TM) BLOOD CULTURE SYSTEM received FDA 510(k) clearance on 1988-01-22, under 510(k) number K875273.

Who is the listed applicant for BITEK(TM) BLOOD CULTURE SYSTEM?

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

What is the FDA product code for BITEK(TM) BLOOD CULTURE SYSTEM?

The FDA product code for BITEK(TM) BLOOD CULTURE SYSTEM is JSG.

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 Definitive Diagnostics, 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.

K875259BITEK(TM) BLOOD CULTURE SYSTEM

Related Devices (Code: JSG)

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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.K881557TRYPTONEAcumedia Manufacturers, Inc.K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.K881533BLOOD AGAR BASE NO. 2Acumedia Manufacturers, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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