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)

BIPHASIC BLOOD CULTURE BOTTLE

K-Number: K842036 · 1984-06-01

ApplicantGibco Laboratories Life Technologies, Inc.
Decision Date1984-06-01
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIPHASIC BLOOD CULTURE BOTTLE is the device name listed in this FDA 510(k) record. The listed applicant is Gibco Laboratories Life Technologies, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K842036. 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 BIPHASIC BLOOD CULTURE BOTTLE?

BIPHASIC BLOOD CULTURE BOTTLE is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Gibco Laboratories Life Technologies, Inc.. The 510(k) number is K842036.

When did BIPHASIC BLOOD CULTURE BOTTLE receive FDA 510(k) clearance?

BIPHASIC BLOOD CULTURE BOTTLE received FDA 510(k) clearance on 1984-06-01, under 510(k) number K842036.

Who is the listed applicant for BIPHASIC BLOOD CULTURE BOTTLE?

The FDA 510(k) record lists Gibco Laboratories Life Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPHASIC BLOOD CULTURE BOTTLE?

The FDA product code for BIPHASIC BLOOD CULTURE BOTTLE 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 Gibco Laboratories Life Technologies, 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.

K871855SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORMK871541MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226K870134MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PREK864755PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORMK864014LOMBARD DOWELL AGAR BASEK863821MUELLER HINTON AGAR W/4%NACL AND OXACILLIN

View all 67 devices →

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

View on FDA Database →

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

↑