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FDA 510(k)

SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY

K-Number: K852665 · 1985-08-13

ApplicantSyncor Intl. Corp.
Decision Date1985-08-13
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K852665. The device is classified under product code JWZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY?

SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K852665.

When did SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY receive FDA 510(k) clearance?

SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY received FDA 510(k) clearance on 1985-08-13, under 510(k) number K852665.

Who is the listed applicant for SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA 510(k) record lists Syncor Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA product code for SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY is JWZ.

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Other records listing Syncor Intl. Corp. as applicant

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Related Devices (Code: JWZ)

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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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