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FDA 510(k)

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE

K-Number: K842874 · 1984-09-12

ApplicantAmerican Micro Scan
Decision Date1984-09-12
Product CodeJTA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE 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 1984-09-12 under 510(k) number K842874. The device is classified under product code JTA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOMETRIC BLOOD CULTURE VIALS, AEROBE?

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is American Micro Scan. The 510(k) number is K842874.

When did RADIOMETRIC BLOOD CULTURE VIALS, AEROBE receive FDA 510(k) clearance?

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842874.

Who is the listed applicant for RADIOMETRIC BLOOD CULTURE VIALS, AEROBE?

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 RADIOMETRIC BLOOD CULTURE VIALS, AEROBE?

The FDA product code for RADIOMETRIC BLOOD CULTURE VIALS, AEROBE is JTA.

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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: JTA)

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.

K954923BACTEC FUNGAL MEDIUMBecton Dickinson Diagnostic Instrument SystemsK910835BACTEC NR-860Bd Becton Dickinson Vacutainer Systems PreanalyticK865021BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK853011BACTEC NR-730 BACTERIAL DETECTION SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK842279BECTEC NR-660 BACTERIAL DETECT SYSBd Becton Dickinson Vacutainer Systems PreanalyticK834264REVERSE-FLOW SYSTEMApplied Polytechnology, 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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