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FDA 510(k)

SLIDEX STREPTO-KIT

K-Number: K905020 · 1991-01-28

ApplicantVitek Systems, Inc.
Decision Date1991-01-28
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SLIDEX STREPTO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K905020. 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 SLIDEX STREPTO-KIT?

SLIDEX STREPTO-KIT is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K905020.

When did SLIDEX STREPTO-KIT receive FDA 510(k) clearance?

SLIDEX STREPTO-KIT received FDA 510(k) clearance on 1991-01-28, under 510(k) number K905020.

Who is the listed applicant for SLIDEX STREPTO-KIT?

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

What is the FDA product code for SLIDEX STREPTO-KIT?

The FDA product code for SLIDEX STREPTO-KIT 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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