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FDA 510(k)

SPOTTEST 10% SODIUM DESOXYCHOLATE

K-Number: K870716 · 1987-04-03

ApplicantDifco Laboratories, Inc.
Decision Date1987-04-03
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTTEST 10% SODIUM DESOXYCHOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1987-04-03 under 510(k) number K870716. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTTEST 10% SODIUM DESOXYCHOLATE?

SPOTTEST 10% SODIUM DESOXYCHOLATE is a medical device that received FDA 510(k) clearance on 1987-04-03. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K870716.

When did SPOTTEST 10% SODIUM DESOXYCHOLATE receive FDA 510(k) clearance?

SPOTTEST 10% SODIUM DESOXYCHOLATE received FDA 510(k) clearance on 1987-04-03, under 510(k) number K870716.

Who is the listed applicant for SPOTTEST 10% SODIUM DESOXYCHOLATE?

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

What is the FDA product code for SPOTTEST 10% SODIUM DESOXYCHOLATE?

The FDA product code for SPOTTEST 10% SODIUM DESOXYCHOLATE is JTO.

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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.

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