FDA 510(k)

LACTALBUMIN HYDROLYSATE MED. W/HANKS

K-Number: K833391 · 1983-11-03

Decision Date1983-11-03

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

LACTALBUMIN HYDROLYSATE MED. W/HANKS is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833391. 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 LACTALBUMIN HYDROLYSATE MED. W/HANKS?

LACTALBUMIN HYDROLYSATE MED. W/HANKS is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Sigma Chemical Co.. The 510(k) number is K833391.

When did LACTALBUMIN HYDROLYSATE MED. W/HANKS receive FDA 510(k) clearance?

LACTALBUMIN HYDROLYSATE MED. W/HANKS received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833391.

Who is the listed applicant for LACTALBUMIN HYDROLYSATE MED. W/HANKS?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LACTALBUMIN HYDROLYSATE MED. W/HANKS?

The FDA product code for LACTALBUMIN HYDROLYSATE MED. W/HANKS is KIT.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: 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.