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FDA 510(k)

VIVID CHLAMYDIA(TM)

K-Number: K872148 · 1987-08-19

ApplicantSeragen Diagnostics, Inc.
Decision Date1987-08-19
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIVID CHLAMYDIA(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-08-19 under 510(k) number K872148. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVID CHLAMYDIA(TM)?

VIVID CHLAMYDIA(TM) is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K872148.

When did VIVID CHLAMYDIA(TM) receive FDA 510(k) clearance?

VIVID CHLAMYDIA(TM) received FDA 510(k) clearance on 1987-08-19, under 510(k) number K872148.

Who is the listed applicant for VIVID CHLAMYDIA(TM)?

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

What is the FDA product code for VIVID CHLAMYDIA(TM)?

The FDA product code for VIVID CHLAMYDIA(TM) is LJC.

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Other records listing Seragen Diagnostics, Inc. as applicant

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K851663QUICK-COUNT HEMATOLOGY CONTROLSK852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTEK844743SERATEST ENA(RNP/SM) DETERMINATION

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Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, 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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