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FDA 510(k)

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)

K-Number: K901975 · 1991-03-08

ApplicantSavyon Diagnostics , Ltd.
Decision Date1991-03-08
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) 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 1991-03-08 under 510(k) number K901975. 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 TRUE IGM(TM)?

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) is a medical device that received FDA 510(k) clearance on 1991-03-08. The listed applicant is Savyon Diagnostics , Ltd.. The 510(k) number is K901975.

When did IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) receive FDA 510(k) clearance?

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) received FDA 510(k) clearance on 1991-03-08, under 510(k) number K901975.

Who is the listed applicant for IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)?

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 TRUE IGM(TM)?

The FDA product code for IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) 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.

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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 DEVICEK914327SEROELISA(TM) CHLAMYDIA IGA TEST KITK915281SEROLISA CHLAMYDIA IGG TEST KITK910644IPAZYME (TM) CHLAMYDIA IGG-IGA

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.

K910644IPAZYME (TM) CHLAMYDIA IGG-IGASavyon 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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