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FDA 510(k)

SPOTTEST INDIA INK

K-Number: K851184 · 1985-04-01

Decision Date1985-04-01
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTTEST INDIA INK 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 1985-04-01 under 510(k) number K851184. 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 INDIA INK?

SPOTTEST INDIA INK is a medical device that received FDA 510(k) clearance on 1985-04-01. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K851184.

When did SPOTTEST INDIA INK receive FDA 510(k) clearance?

SPOTTEST INDIA INK received FDA 510(k) clearance on 1985-04-01, under 510(k) number K851184.

Who is the listed applicant for SPOTTEST INDIA INK?

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 INDIA INK?

The FDA product code for SPOTTEST INDIA INK is JTO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Difco Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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