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FDA 510(k)

HAEMOPHILUS/NEISSERIA IDENTIF-PANEL

K-Number: K833027 · 1983-10-28

ApplicantAmerican Micro Scan
Decision Date1983-10-28
Product Code
DecisionSubstantially Equivalent

Device Summary

HAEMOPHILUS/NEISSERIA IDENTIF-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 1983-10-28 under 510(k) number K833027. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMOPHILUS/NEISSERIA IDENTIF-PANEL?

HAEMOPHILUS/NEISSERIA IDENTIF-PANEL is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is American Micro Scan. The 510(k) number is K833027.

When did HAEMOPHILUS/NEISSERIA IDENTIF-PANEL receive FDA 510(k) clearance?

HAEMOPHILUS/NEISSERIA IDENTIF-PANEL received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833027.

Who is the listed applicant for HAEMOPHILUS/NEISSERIA IDENTIF-PANEL?

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

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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.

K870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEK864662CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSK863776MICRODILUTION MIC PANELSK864674MICRODILUTION IDENTIFICATION PANELSK864389CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTK863038GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

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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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