FDA 510(k)

1400 SERIES EVIDENCE COLLECTION KIT

K-Number: K896373 · 1990-02-26

Decision Date1990-02-26

Product CodeGIM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

1400 SERIES EVIDENCE COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Transidyne General Corp.. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K896373. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1400 SERIES EVIDENCE COLLECTION KIT?

1400 SERIES EVIDENCE COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Transidyne General Corp.. The 510(k) number is K896373.

When did 1400 SERIES EVIDENCE COLLECTION KIT receive FDA 510(k) clearance?

1400 SERIES EVIDENCE COLLECTION KIT received FDA 510(k) clearance on 1990-02-26, under 510(k) number K896373.

Who is the listed applicant for 1400 SERIES EVIDENCE COLLECTION KIT?

The FDA 510(k) record lists Transidyne General Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1400 SERIES EVIDENCE COLLECTION KIT?

The FDA product code for 1400 SERIES EVIDENCE COLLECTION KIT is GIM.

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Other records listing Transidyne General Corp. as applicant

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Related Devices (Code: GIM)

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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.