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FDA 510(k)

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT

K-Number: K864128 · 1987-04-29

ApplicantDiagnostic Technology, Inc.
Decision Date1987-04-29
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1987-04-29 under 510(k) number K864128. 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 CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT?

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K864128.

When did CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT receive FDA 510(k) clearance?

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT received FDA 510(k) clearance on 1987-04-29, under 510(k) number K864128.

Who is the listed applicant for CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT?

The FDA 510(k) record lists Diagnostic Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT?

The FDA product code for CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT is LJP.

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Other records listing Diagnostic Technology, 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.

K896378LYME-CHECK(TM) TEST KITK903612EBV/EA-CHECK TM TEST KITK890819HSV-CHECK(TM) TEST KITK891542EBNA-CHECK(TM) TEST KITK890639RESUBMITTED EBV/IGM-CHECK TEST KITK871373EBV-CHECK(TM) TEST KIT (IGG)

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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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