IPAZYME (TM) CHLAMYDIA IGG-IGA— 510(k) K910644

Name: FDA 510(k) clearance K910644
Creator: U.S. Food and Drug Administration
Published: 1991-03-19

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K910644 for IPAZYME (TM) CHLAMYDIA IGG-IGA, Substantially Equivalent on 1991-03-19. Applicant: Savyon Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Savyon Diagnostics , Ltd.
Product code: Code LKH
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1991-02-14
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashdod, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKH

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K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)1991-03-08
K882674 — IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT1989-08-15
K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM1989-06-23
K852869 — SELECTICULT-CHLAMYDIA1985-09-19
K842151 — CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT1984-07-20

More clearances from Savyon Diagnostics , Ltd.

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K921045 — DIASLIDE URINE CULTURING DEVICE1992-09-28
K914327 — SEROELISA(TM) CHLAMYDIA IGA TEST KIT1992-06-09
K915281 — SEROLISA CHLAMYDIA IGG TEST KIT1992-03-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.