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FDA 510(k)

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

K-Number: K863038 · 1986-09-30

ApplicantAmerican Micro Scan
Decision Date1986-09-30
Product CodeLQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL is the device name listed in this FDA 510(k) record. The listed applicant is American Micro Scan. It received FDA 510(k) clearance on 1986-09-30 under 510(k) number K863038. The device is classified under product code LQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL?

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL is a medical device that received FDA 510(k) clearance on 1986-09-30. The listed applicant is American Micro Scan. The 510(k) number is K863038.

When did GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL receive FDA 510(k) clearance?

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL received FDA 510(k) clearance on 1986-09-30, under 510(k) number K863038.

Who is the listed applicant for GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL?

The FDA 510(k) record lists American Micro Scan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL?

The FDA product code for GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL is LQL.

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Other records listing American Micro Scan 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.

K864662CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSK870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEK863776MICRODILUTION MIC PANELSK864674MICRODILUTION IDENTIFICATION PANELSK864389CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTK862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL

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Related Devices (Code: LQL)

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.

K972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90Accumed Intl., Inc.K961968BBLCRYSTAL GRAM-POSITIVE ID SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK961730RAPID GRAM-POSITIVE ID SYSTEMBecton Dickinson Microbiology SystemsK952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)Biomerieux Vitek, Inc.K925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDBiomerieux Vitek, Inc.K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAVitek Systems, 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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