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FDA 510(k)

GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL

K-Number: K862642 · 1986-09-11

ApplicantAmerican Micro Scan
Decision Date1986-09-11
Product CodeLQM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM NEGATIVE 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 1986-09-11 under 510(k) number K862642. The device is classified under product code LQM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL?

GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is American Micro Scan. The 510(k) number is K862642.

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

GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL received FDA 510(k) clearance on 1986-09-11, under 510(k) number K862642.

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

The FDA product code for GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL is LQM.

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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 TESTK863038GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

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Related Devices (Code: LQM)

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.

K923313ROCHE OXI/FERM IIRoche Diagnostic Systems, Inc.K925915VITEK RAPID CALL-GRAM NEGATIV IDENT CARDBiomerieux Vitek, Inc.K912897SCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK911429VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDVitek Systems, Inc.K890057SENSITITRE AUTO ID PLATE AP80Radiometer America, Inc.K851528PASCO GRAM NEGATIVE IDENTIFICATION SYSTEMPasco Laboratories, 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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