COMBION SKIN TEST— 510(k) K830688

Substantially Equivalent

Nicholas H. Maganias

FDA 510(k) clearance K830688 for COMBION SKIN TEST, Substantially Equivalent on 1983-03-31. Applicant: Nicholas H. Maganias. Device class: 1.

Clearance details

Applicant: Nicholas H. Maganias
Product code: Code LKH
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1983-03-04
Decision date: 1983-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code LKH

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K882674 — IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT1989-08-15
K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM1989-06-23
K852869 — SELECTICULT-CHLAMYDIA1985-09-19

More clearances from Nicholas H. Maganias

K833999 — COMBION SKIN TEST - FOUR PRONG1984-09-05

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