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FDA 510(k)

BACTIGEN(R) MENINGITIDIS PANEL

K-Number: K884965 · 1989-02-07

ApplicantArmkel, LLC
Decision Date1989-02-07
Product CodeGWC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN(R) MENINGITIDIS PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K884965. The device is classified under product code GWC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIGEN(R) MENINGITIDIS PANEL?

BACTIGEN(R) MENINGITIDIS PANEL is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Armkel, LLC. The 510(k) number is K884965.

When did BACTIGEN(R) MENINGITIDIS PANEL receive FDA 510(k) clearance?

BACTIGEN(R) MENINGITIDIS PANEL received FDA 510(k) clearance on 1989-02-07, under 510(k) number K884965.

Who is the listed applicant for BACTIGEN(R) MENINGITIDIS PANEL?

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 BACTIGEN(R) MENINGITIDIS PANEL?

The FDA product code for BACTIGEN(R) MENINGITIDIS PANEL is GWC.

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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

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Related Devices (Code: GWC)

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.

K884966BACTIGEN(R) S. PNEUMONIAEArmkel, LLCK870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEAmerican Micro ScanK862848LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110Lkb Instruments, Inc.K842239VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.K841376WELLCOGEN S. PNEUMONIAEWellcome DiagnosticsK831887BACTIGEN S. PNEUMONIAEArmkel, LLC

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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