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FDA 510(k)

STREPTOCOCCUS GR. B CONTROL

K-Number: K840513 · 1984-03-23

ApplicantScientific Device Laboratory, Inc.
Decision Date1984-03-23
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS GR. B 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 K840513. 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 GR. B CONTROL?

STREPTOCOCCUS GR. B 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 K840513.

When did STREPTOCOCCUS GR. B CONTROL receive FDA 510(k) clearance?

STREPTOCOCCUS GR. B CONTROL received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840513.

Who is the listed applicant for STREPTOCOCCUS GR. B 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 GR. B CONTROL?

The FDA product code for STREPTOCOCCUS GR. B 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.

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