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FDA 510(k)

SPOTTEST CALCOFLUOR WHITE REAGENT

K-Number: K860795 · 1986-03-12

ApplicantDifco Laboratories, Inc.
Decision Date1986-03-12
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPOTTEST CALCOFLUOR WHITE REAGENT 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 1986-03-12 under 510(k) number K860795. 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 CALCOFLUOR WHITE REAGENT?

SPOTTEST CALCOFLUOR WHITE REAGENT is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K860795.

When did SPOTTEST CALCOFLUOR WHITE REAGENT receive FDA 510(k) clearance?

SPOTTEST CALCOFLUOR WHITE REAGENT received FDA 510(k) clearance on 1986-03-12, under 510(k) number K860795.

Who is the listed applicant for SPOTTEST CALCOFLUOR WHITE REAGENT?

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 CALCOFLUOR WHITE REAGENT?

The FDA product code for SPOTTEST CALCOFLUOR WHITE REAGENT is LED.

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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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