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FDA 510(k)

SEROELISA(TM) CHLAMYDIA IGA TEST KIT

K-Number: K914327 · 1992-06-09

ApplicantSavyon Diagnostics , Ltd.
Decision Date1992-06-09
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROELISA(TM) CHLAMYDIA IGA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Savyon Diagnostics , Ltd.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K914327. 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 SEROELISA(TM) CHLAMYDIA IGA TEST KIT?

SEROELISA(TM) CHLAMYDIA IGA TEST KIT is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Savyon Diagnostics , Ltd.. The 510(k) number is K914327.

When did SEROELISA(TM) CHLAMYDIA IGA TEST KIT receive FDA 510(k) clearance?

SEROELISA(TM) CHLAMYDIA IGA TEST KIT received FDA 510(k) clearance on 1992-06-09, under 510(k) number K914327.

Who is the listed applicant for SEROELISA(TM) CHLAMYDIA IGA TEST KIT?

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

What is the FDA product code for SEROELISA(TM) CHLAMYDIA IGA TEST KIT?

The FDA product code for SEROELISA(TM) CHLAMYDIA IGA TEST KIT is LJC.

Related Clinical Trials

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Other records listing Savyon Diagnostics , Ltd. 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.

K921045DIASLIDE URINE CULTURING DEVICEK915281SEROLISA CHLAMYDIA IGG TEST KITK910644IPAZYME (TM) CHLAMYDIA IGG-IGAK901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)

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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