FDA 510(k)

BME AMINO ACIDS 100X

K-Number: K850236 · 1985-03-07

ApplicantHazleton Research Products, Inc.

Decision Date1985-03-07

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BME AMINO ACIDS 100X is the device name listed in this FDA 510(k) record. The listed applicant is Hazleton Research Products, Inc.. It received FDA 510(k) clearance on 1985-03-07 under 510(k) number K850236. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BME AMINO ACIDS 100X?

BME AMINO ACIDS 100X is a medical device that received FDA 510(k) clearance on 1985-03-07. The listed applicant is Hazleton Research Products, Inc.. The 510(k) number is K850236.

When did BME AMINO ACIDS 100X receive FDA 510(k) clearance?

BME AMINO ACIDS 100X received FDA 510(k) clearance on 1985-03-07, under 510(k) number K850236.

Who is the listed applicant for BME AMINO ACIDS 100X?

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

What is the FDA product code for BME AMINO ACIDS 100X?

The FDA product code for BME AMINO ACIDS 100X is KIT.

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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.