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FDA 510(k)

HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

K-Number: K912778 · 1992-02-18

Decision Date1992-02-18
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Sensititre Microbiology A Div. of Radiometer. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K912778. 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 HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Sensititre Microbiology A Div. of Radiometer. The 510(k) number is K912778.

When did HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE receive FDA 510(k) clearance?

HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE received FDA 510(k) clearance on 1992-02-18, under 510(k) number K912778.

Who is the listed applicant for HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

The FDA 510(k) record lists Sensititre Microbiology A Div. of Radiometer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

The FDA product code for HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE is JWY.

Related Clinical Trials

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.

Other records listing Sensititre Microbiology A Div. of Radiometer 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.

Related Devices (Code: JWY)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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