IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)— 510(k) K901975

Name: FDA 510(k) clearance K901975
Creator: U.S. Food and Drug Administration
Published: 1991-03-08

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K901975 for IPAZYME(TM) CHLAMYDIA TRUE IGM(TM), Substantially Equivalent on 1991-03-08. 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: 1990-05-01
Decision date: 1991-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashdod, IL

Download summary PDF View on FDA.gov ↗

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K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA1991-03-19
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K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM1989-06-23
K852869 — SELECTICULT-CHLAMYDIA1985-09-19
K842151 — CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT1984-07-20

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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

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