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510(k) K842247

MELOY AUTOANTIBODY TEST SYS by Meloy Laboratories, Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1984
Date Received
June 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

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  • K820265 — ANA TEST (MOUSE LIVER SUBSTRATE) (February 12, 1982)
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  • K811178 — HUMAN IGG-ALBUMIN TEST KIT (May 15, 1981)
  • K792562 — IMMUNOSTAT TSH TEST (January 16, 1980)
  • K791493 — ANTI-NUCLEAR ANTIBODY TEST (September 24, 1979)
  • K791065 — IMMUNOSPOT TSH TEST (July 30, 1979)

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