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FDA 510(k)

IPAZYME (TM) CHLAMYDIA IGG-IGA

K-Number: K910644 · 1991-03-19

ApplicantSavyon Diagnostics , Ltd.
Decision Date1991-03-19
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IPAZYME (TM) CHLAMYDIA IGG-IGA 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 1991-03-19 under 510(k) number K910644. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPAZYME (TM) CHLAMYDIA IGG-IGA?

IPAZYME (TM) CHLAMYDIA IGG-IGA is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Savyon Diagnostics , Ltd.. The 510(k) number is K910644.

When did IPAZYME (TM) CHLAMYDIA IGG-IGA receive FDA 510(k) clearance?

IPAZYME (TM) CHLAMYDIA IGG-IGA received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910644.

Who is the listed applicant for IPAZYME (TM) CHLAMYDIA IGG-IGA?

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 IPAZYME (TM) CHLAMYDIA IGG-IGA?

The FDA product code for IPAZYME (TM) CHLAMYDIA IGG-IGA is LKH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 DEVICEK914327SEROELISA(TM) CHLAMYDIA IGA TEST KITK915281SEROLISA CHLAMYDIA IGG TEST KITK901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)

Related Devices (Code: LKH)

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.

K901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)Savyon Diagnostics , Ltd.K882674IMMU-MARK(TM) CHLAMYDIA IGG/IGA KITIcn ImmunobiologicalsK893669CELLMATICS SHLAMYDIA DETECTION SYSTEMDifco Laboratories, Inc.K852869SELECTICULT-CHLAMYDIAScott Laboratories, Inc.K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITBartels Immunodiagnostic Supplies, Inc.K830688COMBION SKIN TESTNicholas H. Maganias

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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