ACCUTEX SLE LATEX TEST— 510(k) K924248

Substantially Equivalent

J.S. Medical Assoc.

FDA 510(k) clearance K924248 for ACCUTEX SLE LATEX TEST, Substantially Equivalent on 1992-11-02. Applicant: J.S. Medical Assoc.. Device class: 2.

Clearance details

Applicant: J.S. Medical Assoc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1992-08-24
Decision date: 1992-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from J.S. Medical Assoc.

K932752 — VISI-SPOT1993-11-05
K932688 — EYE SPOT IM TEST1993-09-08
K932180 — EYE SPOT CRP TEST1993-08-23
K932551 — ACCUTEX IM LATEX TEST1993-08-09
K926112 — ACCUTEX BETA-HCG TEST1993-07-28

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