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)

BACTOGEN-H. INFLUENZAE TYPE B

K-Number: K800493 · 1980-04-04

ApplicantArmkel, LLC
Decision Date1980-04-04
Product CodeGRO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTOGEN-H. INFLUENZAE TYPE B is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800493. The device is classified under product code GRO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTOGEN-H. INFLUENZAE TYPE B?

BACTOGEN-H. INFLUENZAE TYPE B is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Armkel, LLC. The 510(k) number is K800493.

When did BACTOGEN-H. INFLUENZAE TYPE B receive FDA 510(k) clearance?

BACTOGEN-H. INFLUENZAE TYPE B received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800493.

Who is the listed applicant for BACTOGEN-H. INFLUENZAE TYPE B?

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

What is the FDA product code for BACTOGEN-H. INFLUENZAE TYPE B?

The FDA product code for BACTOGEN-H. INFLUENZAE TYPE B is GRO.

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 Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

View all 68 devices →

Related Devices (Code: GRO)

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.

K851271LEGIONELLA CULTURE CONFIRMATIN KITGen-Probe, Inc.K834067LEGIONELLA DIFFERENTIATION DISKRemel Co.K802423PHADEBACT HAEMOPHILUS TESTPharmacia, 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.

↑