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FDA 510(k)

QUICK-LYTE

K-Number: K850209 · 1985-02-27

ApplicantSeragen Diagnostics, Inc.
Decision Date1985-02-27
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICK-LYTE is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850209. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICK-LYTE?

QUICK-LYTE is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K850209.

When did QUICK-LYTE receive FDA 510(k) clearance?

QUICK-LYTE received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850209.

Who is the listed applicant for QUICK-LYTE?

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

What is the FDA product code for QUICK-LYTE?

The FDA product code for QUICK-LYTE is JGS.

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Related Devices (Code: JGS)

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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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