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FDA 510(k)

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

K-Number: K854447 · 1986-01-03

ApplicantAmerican Micro Scan
Decision Date1986-01-03
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST 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 1986-01-03 under 510(k) number K854447. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST?

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is American Micro Scan. The 510(k) number is K854447.

When did IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST receive FDA 510(k) clearance?

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854447.

Who is the listed applicant for IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST?

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 IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST?

The FDA product code for IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST is GTZ.

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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: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, 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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