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FDA 510(k)

BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM

K-Number: K962423 · 1996-08-02

ApplicantBecton Dickinson Microbiology Systems
Decision Date1996-08-02
Product CodeJST
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Microbiology Systems. It received FDA 510(k) clearance on 1996-08-02 under 510(k) number K962423. The device is classified under product code JST. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM?

BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K962423.

When did BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM receive FDA 510(k) clearance?

BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM received FDA 510(k) clearance on 1996-08-02, under 510(k) number K962423.

Who is the listed applicant for BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM?

The FDA 510(k) record lists Becton Dickinson Microbiology Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM?

The FDA product code for BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM is JST.

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Other records listing Becton Dickinson Microbiology Systems 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.

K993577CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISCK984631BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYK981517CEFDINIR, 5 UG, SENSI-DISCK980683TROVAFLOXACIN 10G, SENSI-DISCK974578GREPAFLOXACIN, 5 MG, SENSI-DISCK970333BACTEC MYCO/F LYTIC CULTURE VIALS

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Related Devices (Code: JST)

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.

K854732API 50 CHB (CULTURE MEDIA)Dms Products, Inc.K841661SYNTHETIC BROTH A.O.A.C.Oxoid U.S.A., Inc.K832051RIM-HAEMOPHILUS 1 & 2Austin Biological LaboratoriesK832239RIM-HAEMOPHILUS 2Austin Biological LaboratoriesK831349STREPTOCOCUS ID PLATEGranite Diagnostics, 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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