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FDA 510(k)

CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT

K-Number: K860179 · 1986-03-10

ApplicantDifco Laboratories, Inc.
Decision Date1986-03-10
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CELLMATICS CHLAMYDIA MONOCLONAL DFA 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 1986-03-10 under 510(k) number K860179. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT?

CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K860179.

When did CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT receive FDA 510(k) clearance?

CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT received FDA 510(k) clearance on 1986-03-10, under 510(k) number K860179.

Who is the listed applicant for CELLMATICS CHLAMYDIA MONOCLONAL DFA 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 CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT?

The FDA product code for CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT is LJP.

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Other records listing Difco Laboratories, Inc. as applicant

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Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTNeogenexK901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, 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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