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FDA 510(k)

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES

K-Number: K854490 · 1985-12-27

ApplicantAmerican Micro Scan
Decision Date1985-12-27
Product CodeGRP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES 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 1985-12-27 under 510(k) number K854490. The device is classified under product code GRP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES?

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is American Micro Scan. The 510(k) number is K854490.

When did IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES receive FDA 510(k) clearance?

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES received FDA 510(k) clearance on 1985-12-27, under 510(k) number K854490.

Who is the listed applicant for IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES?

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 DIRECT HEMOPHILUS INFLUENZAE TYPE B TES?

The FDA product code for IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES is GRP.

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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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Related Devices (Code: GRP)

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.

K884967BACTIGEN(R) H. INFLUENZAE TYPE BArmkel, LLCK831525H-FLU B ELISA TESTSeragen Diagnostics, Inc.K823348H. INFLUENZA B ANTISERA FOR CIEDiagnostica, Inc.K821266BBL DIRECTIGEN MENINGITIS TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK820192HAEMOPHILUS INFLUENZAE TYPE B ANTISERUMHyland Therapeutic Div., Travenol Laboratories

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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