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FDA 510(k)

SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR

K-Number: K851481 · 1985-04-29

ApplicantDifco Laboratories, Inc.
Decision Date1985-04-29
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR 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 1985-04-29 under 510(k) number K851481. The device is classified under product code LED. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR?

SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K851481.

When did SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR receive FDA 510(k) clearance?

SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851481.

Who is the listed applicant for SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR?

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 IODINE SOLUTION DOBELL & O'CONNOR?

The FDA product code for SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR is LED.

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Other records listing Difco Laboratories, Inc. as applicant

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Related Devices (Code: LED)

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.

K051409SLIVASUREScandinavian Formulas, Inc.K023046SST SALIVA SUPPORTING TABLETSSinclair Pharmaceuticals, Ltd.K860795SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.K860319MEGACOLORCytocolor, Inc.K860316PANOPTIKONCytocolor, Inc.K860321LYSOCOLORCytocolor, Inc.

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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