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FDA 510(k)

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

K-Number: K854615 · 1986-01-28

ApplicantSerono Diagnostics, Inc.
Decision Date1986-01-28
Product CodeLKI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-01-28 under 510(k) number K854615. The device is classified under product code LKI. It was reviewed by the MI advisory panel. Product code LKI falls under the category of Chemistry, which covers automated chemistry analyzers and related reagents. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES?

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES is a medical device that received FDA 510(k) clearance on 1986-01-28. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K854615.

When did MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES receive FDA 510(k) clearance?

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES received FDA 510(k) clearance on 1986-01-28, under 510(k) number K854615.

Who is the listed applicant for MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES?

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

What is the FDA product code for MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES?

The FDA product code for MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES is LKI. This falls under the Chemistry category.

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Other records listing Serono Diagnostics, 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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Related Devices (Code: LKI)

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.

K914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYStellar Bio Systems, Inc.K905531LUPUS(LE)-LATEX TESTImmco Diagnostics, Inc.K894625CHLAMYDIA (LGV-1)Bion Ent., Ltd.K883776BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDEBtc Corp.K830342CULUTURE SET CHLAMYDIA ISOLATION ANDImmulok, 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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