FDA 510(k)

BILE SALTS MIXTURE

K-Number: K833211 · 1983-10-27

Decision Date1983-10-27

Product CodeJKS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

BILE SALTS MIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Acumedia Manufacturers, Inc.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K833211. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILE SALTS MIXTURE?

BILE SALTS MIXTURE is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K833211.

When did BILE SALTS MIXTURE receive FDA 510(k) clearance?

BILE SALTS MIXTURE received FDA 510(k) clearance on 1983-10-27, under 510(k) number K833211.

Who is the listed applicant for BILE SALTS MIXTURE?

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

What is the FDA product code for BILE SALTS MIXTURE?

The FDA product code for BILE SALTS MIXTURE is JKS.

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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.