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FDA 510(k)

GRAM NEGATIVE COMBO PANEL TYPE 3

K-Number: K861584 · 1986-06-17

ApplicantAmerican Micro Scan
Decision Date1986-06-17
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM NEGATIVE COMBO PANEL TYPE 3 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 1986-06-17 under 510(k) number K861584. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM NEGATIVE COMBO PANEL TYPE 3?

GRAM NEGATIVE COMBO PANEL TYPE 3 is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is American Micro Scan. The 510(k) number is K861584.

When did GRAM NEGATIVE COMBO PANEL TYPE 3 receive FDA 510(k) clearance?

GRAM NEGATIVE COMBO PANEL TYPE 3 received FDA 510(k) clearance on 1986-06-17, under 510(k) number K861584.

Who is the listed applicant for GRAM NEGATIVE COMBO PANEL TYPE 3?

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 COMBO PANEL TYPE 3?

The FDA product code for GRAM NEGATIVE COMBO PANEL TYPE 3 is JWY.

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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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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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