FDA 510(k)

GEMENI AST-LTS REAGENTS

K-Number: K851267 · 1985-04-29

ApplicantElectro-Nucleonics Laboratories, Inc.

Decision Date1985-04-29

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GEMENI AST-LTS REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851267. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMENI AST-LTS REAGENTS?

GEMENI AST-LTS REAGENTS is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K851267.

When did GEMENI AST-LTS REAGENTS receive FDA 510(k) clearance?

GEMENI AST-LTS REAGENTS received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851267.

Who is the listed applicant for GEMENI AST-LTS REAGENTS?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEMENI AST-LTS REAGENTS?

The FDA product code for GEMENI AST-LTS REAGENTS is CIT.

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Official Source

View on FDA Database →

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