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FDA 510(k)

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE

K-Number: K965190 · 1997-03-19

ApplicantAccumed Intl., Inc.
Decision Date1997-03-19
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K965190. 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 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K965190.

When did SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE receive FDA 510(k) clearance?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE received FDA 510(k) clearance on 1997-03-19, under 510(k) number K965190.

Who is the listed applicant for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE?

The FDA 510(k) record lists Accumed Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE?

The FDA product code for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE is JWY.

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Related Devices (Code: JWY)

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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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