FDA 510(k)

STREPTOCOCCUS PNEUMONIAE CONTROL

K-Number: K840512 · 1984-03-23

ApplicantScientific Device Laboratory, Inc.

Decision Date1984-03-23

Product CodeGTY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS PNEUMONIAE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Laboratory, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840512. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREPTOCOCCUS PNEUMONIAE CONTROL?

STREPTOCOCCUS PNEUMONIAE CONTROL is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Scientific Device Laboratory, Inc.. The 510(k) number is K840512.

When did STREPTOCOCCUS PNEUMONIAE CONTROL receive FDA 510(k) clearance?

STREPTOCOCCUS PNEUMONIAE CONTROL received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840512.

Who is the listed applicant for STREPTOCOCCUS PNEUMONIAE CONTROL?

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

What is the FDA product code for STREPTOCOCCUS PNEUMONIAE CONTROL?

The FDA product code for STREPTOCOCCUS PNEUMONIAE CONTROL is GTY.

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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.